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

Model Number	864017D
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2023
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, images were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 07/2024).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: device pending return.
Event or Problem Description
It was reported that during a breast tissue marker placement procedure, the deployed marker was allegedly different shaped clip than the one that was mentioned in the label.It was further reported that it should have been a coil shaped marker but the deployed marker is a padlock shaped.There was no reported patient injury.
Additional Manufacturer Narrative
Only one device was involved in this reportable event at the user facility.Additional unused lot samples from the same lot/product catalog number were returned from the customer for evaluation and investigation of this event.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 sealed package of ultraclip dual trigger breast tissue marker and an additional label from the same lot were returned for evaluation.During the visual evaluation, the packaging label of the marker indicated that the wire form was to be coil-shaped.No other anomalies were noted.On functional testing, the marker wire form was deployed, and it was noted to be a coil-shaped wire form.One image was reviewed.The image shows the post-biopsy mammogram to confirm the placement of the breast tissue marker.The shape of the observed marker wire was to be padlock-shaped and located in the upper left breast.No other tissue markers were found at the site, and the breast was extremely dense.No other anomalies were noted on the submitted image.The image review says the identified shape of the coil is the padlock shape; however, the padlock shape is not available for ultraclip dual trigger markers.The returned sealed lot samples confirm that the wire form was noted to be a coiled shape.However, the original sample was not returned for evaluation.The requirement of additional imaging or a wire form being returned for evaluation to confirm the mismatch of shape as described in the device label and the event being reported.Hence, the investigation remains inconclusive for the reported device markings and labeling problems for the unreturned original sample.A definitive root cause for the reported device markings/labelling problem could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.D4 (expiration date: 07/2024).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 breast tissue marker placement procedure, the deployed marker was allegedly different shaped clip than the one that was mentioned in the label.It was further reported that it should have been a coil shaped marker but the deployed marker is a padlock shaped.There was no reported patient injury.

• Brand Name: ULTRACLIP DUAL TRIGGER
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 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: 17206877
• Report Number: 2020394-2023-00455
• Device Sequence Number: 12410202
• Product Code: NEU
• UDI-Device Identifier: 00801741032257
• UDI-Public: (01)00801741032257
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K090547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2023

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 Model Number: 864017D
• Device Catalogue Number: 864017D
• Device Lot Number: HUFV0523
• 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: 06/01/2023
• Supplement Date Received by Manufacturer: 09/12/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2021
• 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