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

Model Number UCTW17

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 05/03/2018

Event Type  malfunction  

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 Description

It was reported that the needle of the breast tissue marker allegedly pierced through the packaging.There was no patient or user contact.

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 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
• Type of Device: IMPLANTABLE CLIP
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD SHANNON LIMITED; san geronimo industrial park; lot #1, road #3, km 79.7; humacao 00791
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 7555170
• MDR Text Key: 109624587
• Report Number: 2020394-2018-00757
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 00801741109416
• UDI-Public: (01)00801741109416
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K152510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1