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

Model Number	47920
Medical Device Problem Codes	Nonstandard Device (1420); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation of the reported event is currently underway.(expiry date: nov2020).
Event or Problem Description
It was reported that upon opening the package, the device allegedly was not clean.It was further reported that the procedure was performed with another device.There was no patient contact.
Additional Manufacturer Narrative
H10:a complaint history review was conducted and it was determined that a device history record (dhr) review was not required.However, based on the reported event, a dhr review was requested to review manufacturing records.The dhr have been reviewed and this lot met all release criteria.One ghiatas localization wire and cannula were returned.The wire was returned with the barb inside the cannula lumen.A gel-like substance was noted on both the wire and the cannula.Although there was not sufficient substance to conduct fourier transform infrared spectroscopy testing, the appearance of the substance was consistent with the lubricant used in the ghiatas manufacturing process.Therefore, the investigation is confirmed for the reported material present on device, specifically excess lubricant (i.E.Nonstandard device).It was determined that excess lubricant was applied during the manufacturing process.Therefore, the root cause is manufacturing-related.H10: d4 (expiry date: nov2020).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 upon opening the package, the device allegedly was not clean.It was further reported that the procedure was performed with another device.There was no patient contact.

• Brand Name: GHIATAS BEADED BREAST LOCALIZATION WIRE
• Common Device Name: LOCALIZATION WIRE
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8016792
• Report Number: 2020394-2018-01949
• Device Sequence Number: 1525389
• Product Code: GDF
• UDI-Device Identifier: 00801741079832
• UDI-Public: (01)00801741079832
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2020

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: REBY2181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Initial Date Received by Manufacturer: 10/05/2018
• Supplement Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 10/29/2018
• Supplement Report FDA Received Date: 04/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1