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

Catalog Number	TKL1110
Medical Device Problem Codes	Material Perforation (2205); Device Contamination with Chemical or Other Material (2944); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2023
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: received one quick connect hub and sterile sleeve for evaluation.Upon visual examination, multiple perforations were observed throughout the sterile sleeve and black residue was noted on the inner side of the quick connect hub.It was also noted the proximal u-clips were not visible.Furthermore, on x-ray examination it was noted that the distal uclip was found to be shifted out of position.Therefore, the investigation is confirmed for the reported premature separation issue as proximal uclips were not visible and distal uclip was noted shifted out of position.And the investigation is confirmed for the identified material perforation and device contamination with chemical or other material as perforation and black residue was noted to the device.A definitive root cause for the alleged premature separation issues is due to the u-clip placement (e.G., shifted out of position).Then, definitive root cause for the identified material perforation and 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.
Event or Problem Description
It was reported that during a bone lesion biopsy procedure, the hub allegedly disconnected from the driver after the second pass.It was further reported that the procedure was completed using another device.There was no reported patient injury.

• Brand Name: TREK BONE LESION BIOPSY KIT
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 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: 18550463
• Report Number: 2020394-2024-00048
• Device Sequence Number: 6402673
• 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: 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): 01/18/2024

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: TKL1110
• Device Lot Number: 0001507704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 01/22/2024
• 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: Unknown