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

Catalog Number	TKL1110
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: two electronic photos were provided and it were reviewed.The first and second provided photos shows a trek bone lesion biopsy kit and a sterile sleeve.Received one connect hub for evaluation.Upon visual evaluation, the residue was also observed on the sterile sleeve and on the outer side of the connect hub.The device appeared to have black residue in the inner side of the connect hub.There were no visual anomalies noted on the device.It was noted that both sides of the proximal u-clips was present.And also it was noted that there wasn't any difficulty taking apart the connector hub and driver.Based on the sample evaluation, the whole investigation is unconfirmed for the reported difficult or delayed separation issue as the u-clips were present in place and there were no issues in connecting or disconnecting the quick connect hub from the driver.And, the investigation is confirmed for the identified device contamination with chemical or other material issue as the black residue was noted in the inner side of the connect hub.A definitive root cause for the reported difficult or delayed separation and identified device contamination with chemical or other material issues 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.H10: d4 (expiration date: 01/2024).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 biopsy procedure at the right hip acetabula bone, the hub was allegedly difficult to remove from the driver.There was no reported patient injury.

• Brand Name: TREK BONE LESION BIOPSY KIT
• Common Device Name: DISPOSABLE BIOPSY
• 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: 18268072
• Report Number: 2020394-2023-01138
• Device Sequence Number: 4006493
• Product Code: KNW
• UDI-Device Identifier: 00801741201455
• UDI-Public: (01)00801741201455
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• 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): 12/01/2023

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: TKL1110
• Device Lot Number: 0001507704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 12/05/2023
• 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: Male