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

Catalog Number	TKDRIVER
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Unclear Information (4052)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
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 device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 04/2028).H11: 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 bone marrow biopsy procedure, there was allegedly had trouble in identifying the serial number on the label.There was no reported patient injury.
Additional Manufacturer Narrative
H10: additional information was received, as it was inquired for the serial number of the device but these devices does not come with the serial numbers, but only the lot numbers.Therefore, this report is no longer being considered a complaint file and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: d4 (expiration date: 04/2028), g3.H11: 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.H3 other text : device not returned.
Event or Problem Description
It was reported that during a bone marrow biopsy procedure, there was allegedly had trouble in identifying the serial number on the label.There was no reported patient injury.
Event or Problem Description
It was reported that during a bone marrow biopsy procedure, there was allegedly had trouble in identifying the serial number on the label.There was no reported patient injury.
Additional Manufacturer Narrative
H10: additional information was received that this event will remain as a complaint and the file was reassessed for reportability and determined to be reportable as malfunction.H10: manufacturing review: the device history records were requested and reviewed.This lot met all release criteria.Investigation summary: the physical device was not returned for evaluation.However, two electronic photos were provided and reviewed.One photo shows a close up of one trek driver label.The label is directly attached to the driver, and the driver can be seen in the background laying on a flat surface.The information directly printed on the trek driver label indicates: ref: tkdriver, lot: 0001456226, date of manufacture: 2022-03-10., (b)(6) rev 1 02/22, label counter#: 0129.The second photo shows a close up on one trek driver case label.The label is directly attached to the black driver case and the case can be seen laying on a flat surface.The information directly printed on the driver case label indicates: ref: tkdriver, lot: 0001456226, date of manufacture: 2022-03-10., (b)(6) rev 1 02/22, gtin ai code: (01), gtin: (00801741201356), label counter# 0113.The information printed on the trek driver label and trek driver case label was verified and determined to meet all procedural requirements for release.Based on the photo review, the reported unclear information is determined to be unconfirmed as the information printed on the trek driver label and trek driver case label is correct and met all procedural requirements for release.This device is not serviceable and has a lot number as opposed to a serial number (s/n).Labeling review: a review of the bd trek power driver instructions for use determined the product labeling documentation is adequate.Per the trek power driver (instructions for use) device description section, the bd trek power driver is a handheld, battery-powered, reusable bone drill.Per the batter life and speed reference led indicator section, the battery is not replaceable, is non-rechargeable, and the device cannot be serviced.The symbols section of the instructions for use provides the symbol for lot number which is listed on the trek driver label.H10: d4 (expiration date: 04/2028), g3, h6 (method).H11: h6 (device, result, conclusion).H11: 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 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: 18325670
• Report Number: 2020394-2023-01259
• Device Sequence Number: 17901118
• Product Code: KNW
• UDI-Device Identifier: 00801741201356
• UDI-Public: (01)00801741201356
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/08/2024

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: 0001456226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: 12/15/2023; 04/12/2024
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 01/10/2024; 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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