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

Catalog Number	TKL1010
Medical Device Problem Codes	Material Perforation (2205); Mechanical Jam (2983); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a bone lesion biopsy procedure, the quick connect hub was allegedly disconnected from the driver.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one quick connect hub and sterile sleeve were returned for evaluation.During visual evaluation, the device appeared to have residue throughout and multiple perforations were observed on the sterile sleeve.No other anomalies were observed to the device.On further observation, it was noted that the quick connect received with the sterile sleeve attached.It was noted the zipper pull was not returned and there were multiple perforations to the sterile sleeve.The hub was visually inspected and noted the proximal uclips were not visible.No other visual anomalies were noted to the device.Functional testing was not performed, due to the condition of the received sample (proximal uclips were not visible).Therefore, the investigation is confirmed for the reported premature separation issue as the uclips were not visible within the quick connect hub.Also, the investigation is confirmed for the identified mechanic jam issue as the zipper pull was not returned and the investigation is confirmed for the identified material perforation as multiple perforations were noted on the sterile sleeve.A definitive root cause for the alleged premature separation issue was due to the u- clips movement within the quick connect hub as the uclip was not visible and a definite root cause for identified multiple perforation issue is due to the movement between the quick connect hub and driver that led to the perforations observed on the sterile sleeve.However, a definite root cause for identified mechanic jam 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.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 : see h10.
Event or Problem Description
It was reported that during a bone lesion biopsy procedure, the quick connect hub was allegedly disconnected from the driver.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.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 BONE LESION 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: 18569126
• Report Number: 2020394-2024-00102
• Device Sequence Number: 18193743
• Product Code: KNW
• UDI-Device Identifier: 00801741201424
• UDI-Public: (01)00801741201424
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 01/31/2024

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: TKL1010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 01/31/2024
• 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 Sex: Female