MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRACOR TWIRL BREAST TISSUE MARKER; IMPLANTABLE CLIP

Model Number	UCTW17
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer, but photos were provided.The lot number for the device was provided.The device history records are currently under review.The device has not been returned for evaluation.The investigation of the reported event is currently underway.(b)(6) 2017).The information provided by bard 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 bard.
Event or Problem Description
It was reported that the needle of the breast tissue marker allegedly pierced through the packaging.There was no patient or user contact.
Additional Manufacturer Narrative
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.The sample was not returned for evaluation.Photos were provided for review.Based on the photo review, the needle exposed through the package can be confirmed.It is unknown whether all sides of the packaging were sealed, as the provided photos did not capture a full image of the entire packaging.Although, the photo review concluded the needle to be exposed through the packaging, the overall investigation is inconclusive for the reported breach of sterile barrier, as it is unknown whether the packaging was sealed on all sides.Per the reported event details, no damage was noted to the shipment box.The devices are received by the msa at the facility.The msa unpacks the received devices, transports by hand to the ultrasound department, and stores the devices in a cabinet.The original device was not returned for evaluation however photos were provided for review.The photo review concluded that the needle was exposed through the packaging, however it is unknown whether all sides of the packaging were sealed as the provided photos did not capture a full image of the entire packaging.Therefore, the definitive root cause for the reported breach of sterility could not be determined based upon the provided information.It is unknown whether the transport or storage of the devices contributed to the reported event.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(expiry date 10/2020).
Event or Problem Description
It was reported that the needle of the breast tissue marker allegedly pierced through the packaging.There was no patient or user contact.

• Brand Name: ULTRACOR TWIRL BREAST TISSUE MARKER
• Common Device Name: IMPLANTABLE CLIP
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7555170
• Report Number: 2020394-2018-00757
• Device Sequence Number: 1261691
• Product Code: NEU
• UDI-Device Identifier: 00801741109416
• UDI-Public: (01)00801741109416
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K152510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2018

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: Other
• Device Expiration Date: 10/28/2020
• Device Model Number: UCTW17
• Device Catalogue Number: UCTW17
• Device Lot Number: HUBX2969
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/03/2018
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 06/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1