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

Catalog Number	TKM1110
Medical Device Problem Codes	Break (1069); Crack (1135); Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H11: section a through f ¿ the information provide 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 cannula allegedly broke and audible break heard.Reportedly, there was difficulty to pull aspirate.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: received one trek biopsy cannula with one loaded biopsy ejector rod and one ejector guide for evaluation.Upon visual evaluation, the sample appeared to have blood residue throughout.Under microscopic observations, a crack was noted to the introducer cannula hub.Due to the nature of the complaint, no functional testing was not performed.Therefore, the investigation is confirmed for the identified crack as crack was noted on the introducer cannula hub.However, the investigation is unconfirmed for the reported break as no break was noted on the cannula hub and the investigation is inconclusive for the reported failure to obtain sample as no further functional testing was performed due to the condition of the returned sample.A definitive root cause for the reported failure to obtain sample, reported break and identified crack issues 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.D4 (unique identifier (udi) #), g3, h6 (device, component, method, result, conclusion) section a through f: the information provide 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
On (b)(6) 2025, a patient underwent for a bone biopsy procedure using trek bone marrow biopsy kit.During the procedure, cannula allegedly broke and audible break heard.Reportedly, there was difficulty to pull aspirate.There was no reported patient injury.

• Brand Name: TREK BONE MARROW BIOPSY KIT
• Common Device Name: BIOPSY INSTRUMENT
• 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: 21855744
• Report Number: 2020394-2025-00580
• Device Sequence Number: 4695725
• Product Code: KNW
• UDI-Device Identifier: 00801741201370
• UDI-Public: (01)00801741201370(11)241007(17)270831(10)0001591513
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 09/03/2025

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: TKM1110
• Device Lot Number: 0001591513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2024
• 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