Indication for Use
The BD Trek™ Bone Marrow Biopsy System (BD Trek™ Power Driver, BD Trek™ Bone Marrow Biopsy Kit) is intended for bone marrow aspiration and biopsy in adult and pediatric patients age 2 and older. The BD Trek™ Bone Lesion Biopsy System (BD Trek™ Power Driver, BD Trek™ Bone Lesion Biopsy Kit) is intended for bone biopsy of the vertebral body and bone lesions. The BD Trek™ Bone Lesion Biopsy System (BD Trek™ Power Driver, BD Trek™ Bone Lesion Biopsy Kit) is intended for bone marrow aspiration and biopsy.
Please note that the BD Trek™ Lesion Biopsy Kit is for use in adult patients.
Contraindications
None known
Warnings
1. Good medical judgment should be exercised in considering biopsy on patients who are receiving anticoagulant therapy or who have a bleeding problem.
2. Post-biopsy patient care may vary with the biopsy technique utilized and the individual patient’s physiological condition. Observation of vital signs and other precautions should be taken to avoid and/or treat potential complications that may be associated with biopsy procedures.
3. The collection of multiple core biopsy samples may help to ensure the detection of any cancer tissue. A “negative” biopsy in the presence of suspicious radiographic findings does not preclude the presence of carcinoma.
4. The Biopsy Kit has been designed for single use only. Reusing this medical device bears the risk of cross-patient contamination as medical devices – particularly those with long and small lumina, joints, and/or crevices before components – are difficult or impossible to clean once body fluids or tissues with potential pyrogenic or microbial contamination have had contact with the medical device for an indeterminable period of time. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications.
5. Do not resterilize the Biopsy Kit. After resterilization, the sterility of the product is not guaranteed because of an indeterminable degree of potential pyrogenic or microbial contamination which may lead to infectious complications. Cleaning, reprocessing, and/or resterilization of the present medical device increases the probability that the device will malfunction due to the potential adverse effects on the components that are influenced by thermal and/or mechanical changes.
6. No modification of this equipment is allowed. Modification of the present medical
device may result in device malfunction.
7. The BD Trek™ Powered Bone Biopsy System should not be used in a Magnetic Resonance Imaging (MRI) Suite.
8. For sternal applications, special consideration should be given to proper needle depth and site of puncture to mitigate potential for through-and-through penetration resulting in serious harm.
Note: After use, the Biopsy Kit may be a potential biohazard. Handle and dispose of in accordance with acceptable medical practice and applicable local, state, and federal laws and regulations. Dispose of sharps in designated sharps disposal containers; these are single-use devices therefore should be disposed appropriately, not recapped or resterilized.
Precautions
1. Use only BD Trek™ Biopsy Kits with the BD Trek™ Power Driver.
2. This product should be used by a physician who is completely familiar with the indications, contraindications, limitations, typical findings and possible side effects of bone biopsy, in particular, those relating to the specific tissue being biopsied.
3. Do not use if package is damaged. Inspect the packaging to ensure that package integrity has not been compromised. The product is sterile unless the seal is broken.
4. Inspect needle components for damaged point, bent shaft or other imperfections prior to use and after each sample is collected. DO NOT USE the device if any imperfection is noted. 5. Applying too much axial force may bend the needle.
Potential Complications
Potential complications associated with bone biopsy, bone marrow biopsy, and aspiration procedures are site specific and include, but are not limited to: infection, pain, bleeding, hematoma, non-target tissue, adjacent tissue injury, and organ or vessel perforation..
