MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRACLIP DUAL TRIGGER; BIOPSY INSTRUMENT

Catalog Number	863017D
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2023
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 return of the sample is pending.However, photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 10/2025).H11: section a through f - the information provided by bd represents all of 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 prior to breast tissue marker placement procedure, a hair was allegedly found on the sterile packaging.The procedure was completed using another device.There was no patient contact.
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: one ultraclip dual trigger breast tissue marker was received for evaluation.During visual evaluation, a piece of hair was observed inside the sealed packaging.Sample was sealed and therefore was not decontaminated.Functional testing was not performed due to the nature of the complaint.Also, two electronic photos were provided and reviewed.In the first photo, one ultra clip dual triggers is shown inside the package in which a hair like material was found with the device.The second photo shows the labelling information which matches with the trackwise details.Therefore, the investigation is confirmed for the reported foreign material as a hair like material was found inside the sealed package.A definitive root cause for the reported foreign body issue could be related to the manufacturing issue.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: b5, d4 (expiry date: 10/2025), g3.H11: section a through f - the information provided by bd represents all of 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 prior to breast tissue marker placement procedure, a hair was allegedly found inside the sterile packaging on the biopsy clip.The procedure was completed using another device.There was no patient contact.

• Brand Name: ULTRACLIP DUAL TRIGGER
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 17710223
• Report Number: 2020394-2023-00668
• Device Sequence Number: 15140823
• Product Code: NEU
• UDI-Device Identifier: 00801741032233
• UDI-Public: (01)00801741032233
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K042341
• 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): 01/16/2024

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: 863017D
• Device Lot Number: HUGY0259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2023
• Supplement Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2022
• 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