MAUDE Adverse Event Report: Bard Peripheral Vascular, Inc. Trek Bone Marrow Biopsy Kit; Biopsy Instrument

Catalog Number	TKM1115
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, a patient underwent a bone marrow biopsy procedure using a trek driver and a trek bone marrow biopsy kit.During the procedure, there was no difficulty inserting the needle hub into the quick connect hub, and it clicked into place as expected.When the quick connect hub was moved to one of the disconnect positions, the needle hub could be removed without resistance.However, difficulty was encountered when attempting to remove the needle from the patient.There was no reported patient injury.
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 return of the sample is pending.However, photos were provided for review.The investigation of the reported event is currently underway.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.

• Brand Name: Trek Bone Marrow 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 50218296
• Report Number: 2020394-2026-02073
• Device Sequence Number: 13406337
• Product Code: KNW
• UDI-Device Identifier: 00801741201387
• UDI-Public: (01)00801741201387(17)281130(10)0001655214
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/21/2026

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: TKM1115
• Device Lot Number: 0001655214
• 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: 07/22/2026
• Supplement Date Received by Manufacturer: 09/03/2026; 09/21/2026
• Initial Report FDA Received Date: 08/12/2026
• Supplement Report FDA Received Date: 09/07/2026; 09/22/2026
• 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