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

Catalog Number	TKM1110
Medical Device Problem Codes	Material Separation (1562); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: the physical device was not returned for evaluation.One electronic video was provided.The video shows one trek driver being held.The quick connect hub is loaded onto the driver, however the sterile sleeve is not present and appears to be removed from the quick connect hub, the trigger cover is torn, and no other anomalies were noted.The driver is activated, the quick connect hub appears to move and a clicking sound was heard during the activation.Based on the video review, the reported difficulty to remove the quick connect hub from the driver could not be confirmed.Therefore, the investigation is confirmed for the identified material separation as sterile sleeve is not present and appears to be removed from the quick connect hub.However, the investigation is inconclusive for the reported difficult or delayed separation as no objective evidence was provided for review.It likely due to user removing during the demonstration.However, a definitive root cause for the alleged difficulty or delayed separation and identified material separation issue 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.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 demo of a bone marrow biopsy procedure, reported that the quick connect hub was difficult to remove from the driver.There was no patient contact.

• 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: 22334220
• Report Number: 2020394-2025-00944
• Device Sequence Number: 9060183
• Product Code: KNW
• UDI-Device Identifier: 00801741201370
• UDI-Public: (01)00801741201370(11)240802(17)260430(10)0001585516
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 06/17/2025

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 Expiration Date: 04/30/2026
• Device Catalogue Number: TKM1110
• Device Lot Number: 0001585516
• 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: 06/16/2025
• Initial Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2024
• 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