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

Catalog Number	TKL1110
Medical Device Problem Codes	Break (1069); Failure to Obtain Sample (2533); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a bone biopsy procedure, the health care professional was allegedly not able to get the core out of the needle.It was further reported that cannula allegedly broken.There was no reported patient injury.
Additional Manufacturer Narrative
H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.However, photos were provided for review.The investigation of the reported event is currently underway.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.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: three electronic photos were provided and it was reviewed.The first photo shows two manual drivers in which an introducer ejector rod was loaded onto one of the manual drivers, a introducer cannula was loaded onto an other manual driver, a biopsy ejector rod was noted to be bent and the user shows a broken part of a biopsy cannula.The second photo shows an introducer ejector rod was loaded the manual driver and a bent biopsy ejector rod.The third photo shows the biopsy cannula in which its upper part (blue colored hub) was noted to be broken.Based on the provided photos, both reported bent and break can be confirmed, however, the reported failure to obtain sample cannot be confirmed.Therefore, the investigation is confirmed for both reported bent and break as the provided photos shows the bent and break of the needles, the investigation is inconclusive for the reported failure to obtain sample as no objective evidence was provided.A definitive root cause for the reported failure to obtain sample, reported break and reported bent could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: g3, h6 (device, method).H11: g4, h6 (result).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.
Event or Problem Description
It was reported that during a bone biopsy procedure, the health care professional was allegedly not able to get the core out of the needle.It was further reported that cannula allegedly broken.There was no reported patient injury.

• Brand Name: TREK BONE LESION BIOPSY KIT
• Common Device Name: DISPOSABLE BIOPSY
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 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: 21032886
• Report Number: 2020394-2024-01921
• Device Sequence Number: 14455084
• Product Code: KNW
• UDI-Device Identifier: 00801741201455
• UDI-Public: (01)00801741201455
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Followup
• Report Date (Section B): 02/14/2025

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: TKL1110
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 12/29/2024
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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