MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. TREK POWER DRIVER; BIOPSY INSTRUMENT

Catalog Number	TKDRIVER
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
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 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.
Event or Problem Description
A patient underwent a biopsy procedure using the trek driver.It was reported that prior to the procedure, the labels do not match.There was no patient contact.
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 power driver inside of trek power driver case.Upon visual evaluation, the trek power driver appeared to be clean.Original product packaging and label were returned referencing lot#0001617047.The adhesive label on the bottom of the driver referenced lot#baw1522300.Three electronic photos were submitted and reviewed.The first photo shows the product label on the bottom of the trek power driver, displaying lot# baw1522300.The second photo shows the trek driver case with an attached product label indicating lot # 0001617047.The third photo shows a cardboard package with the trek driver product label, also indicating lot # 0001617047.Based on the results of the photo review and evaluation, the investigation is confirmed for the reported labeling problem as the lot number on the trek driver case and package does not match with the lot number on the label affixed to the bottom of the trek power driver.The root cause of the labeling problem was determined to be manufacturing related.Labeling review: as the reported issue is labeling issue.Labeling review is required.Three electronic product label photos were provided and reviewed.The first photo shows the product label on the bottom of the trek power driver, displaying lot# baw1522300.The second photo shows the trek driver case with an attached product label indicating lot # 0001617047.The third photo shows a cardboard package with the trek driver product label, also indicating lot # 0001617047.Based on this photo review, the reported labeling discrepancy is confirmed, as the lot number on the trek driver case and package does not match with the lot number on the label affixed to the bottom of the trek power driver.D4 (unique identifier (udi) #), g3, h6 (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
A patient underwent a biopsy procedure using the trek driver.It was reported that prior to the procedure, the labels do not match.There was no patient contact.

• Brand Name: TREK POWER DRIVER
• 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: 23048336
• Report Number: 2020394-2025-01489
• Device Sequence Number: 10038155
• Product Code: KNW
• UDI-Device Identifier: 00801741201356
• UDI-Public: (01)00801741201356(11)250409(17)300528(10)0001617047
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/03/2026

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: TKDRIVER
• Device Lot Number: 0001617047
• 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: 08/25/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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