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	08/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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
On (b)(6) 2025, a patient underwent a biopsy procedure using the trek bone marrow.During the procedure, it was reported that the device allegedly failed to obtain the sample, and the seal was found broken.There was no reported patient injury.
Event or Problem Description
On (b)(6) 2025, a patient underwent a biopsy procedure using the trek bone marrow.During the procedure, it was reported that the device allegedly failed to obtain the sample, and the seal was found broken.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: received one trek bone marrow biopsy cannula for evaluation.Upon visual evaluation, the sample appeared to have blood residue throughout.Under microscopic observations, a crack was noted on 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 issue as a crack was noted on the introducer cannula hub.And the investigation is unconfirmed for the reported break as no break was noted on the returned cannula hub, and the investigation is inconclusive for the reported failure to obtain sample as no further functional testing was performed & as condition of use cannot be replicated.A definitive root cause for the identified crack issue, reported hub break and failure to obtain sample 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.E1, g3, h6 (device, component, method, result, conclusion).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 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: 23013117
• Report Number: 2020394-2025-01454
• Device Sequence Number: 9573882
• Product Code: KNW
• UDI-Device Identifier: 00801741201370
• UDI-Public: (01)00801741201370(17)280531(10)0001625428
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2025

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: 0001625428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 12/02/2025
• 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 Age: 80 YR
• Patient Sex: Male