MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. TREK BONE LESION BIOPSY KIT; BIOPSY INSTRUMENT

Catalog Number	TKL1010
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Unintended Movement (3026); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to a bone lesion biopsy procedure, the needle allegedly wobbled.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one quick connect hub was received for evaluation.Upon visual evaluation, the device appeared to have black residue on the inner side of the quick connect hub.It was noted the proximal u-clips were not visible.Functional testing was not performed, due to the as received sample condition (uclips not visible and noted out of place, unable to connect to power driver).Therefore, the investigation is inconclusive for the reported unintended movement issue as the further functional testing was not performed (u-clips not visible and noted out of place, unable to connect to power driver).The investigation is confirmed for the identified premature separation issue as the device was received with u-clips out of position.And the investigation is confirmed for the identified device contamination with chemical or other material issue as the black residue was noted in the inner side of the connect hub.A definitive root cause for the identified premature separation issue was due to the u-clips not visible and noted out of place.Then, definitive root cause for the remaining reported unintended movement and identified device contamination with chemical or other material issues could not be determined based upon the provided information.It is unknown whether procedural issues contributed to the reported event.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 01/2024) h11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: TREK BONE LESION BIOPSY KIT
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 85281
• Manufacturer (Section G): CAREFUSION MANNFORD; 400 foster rd; mannford OK 74044
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18344482
• Report Number: 2020394-2023-01282
• Device Sequence Number: 6221906
• Product Code: KNW
• UDI-Device Identifier: 00801741201424
• UDI-Public: (01)00801741201424
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K213896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: TKL1010
• Device Lot Number: 0001506745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown