MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. GHIATAS BEADED LOCALIZATION WIRE; BIOPSY INSTRUMENT

Model Number	47920
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The one device belonging to the sole complaint is expected to be returned to bd for evaluation.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes one malfunction event.A review of the events indicated that model 47920 localization wire allegedly had foreign material on the needle, upon removal from the packaging.There was no patient involvement for this one event.
Event or Problem Description
This report summarizes one malfunction event.A review of the events indicated that model 47920 localization wire allegedly had foreign material on the needle, upon removal from the packaging.There was no patient involvement for this one event.
Additional Manufacturer Narrative
The one device has been returned for evaluation.Foreign material was identified on the device.The device is labeled for single use.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.

• Brand Name: GHIATAS BEADED LOCALIZATION WIRE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8485173
• Report Number: 2020394-2019-00224
• Device Sequence Number: 13837352
• Product Code: GDF
• UDI-Device Identifier: 00801741079832
• UDI-Public: (01)00801741079832
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2019

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: No Information
• Device Model Number: 47920
• Device Catalogue Number: 47920
• Device Lot Number: RECV2460
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 10/08/2019
• Patient Sequence Number: 1