MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. GHIATAS; BREAST LOCALIZATION WIRE

Model Number	47920
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the alleged needle break 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.(expiry date: 10/2023).
Event or Problem Description
It was reported that during the breast localization wire placement, the puncture needle was allegedly broken.There was no reported patient injury.

• Brand Name: GHIATAS
• Common Device Name: BREAST LOCALIZATION WIRE
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 12293650
• Report Number: 2020394-2021-01440
• Device Sequence Number: 14620890
• Product Code: GDF
• UDI-Device Identifier: 00801741079832
• UDI-Public: (01)00801741079832
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/27/2021

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: 47920
• Device Catalogue Number: 47920
• Device Lot Number: REEY1470
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 08/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other