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

Model Number	47720
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices for the two malfunctions have been returned to the manufacturer for evaluation.The investigations of the reported malfunctions are currently underway.The devices are labeled for single use.
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicated that model 47720 biopsy instrument allegedly experienced device markings issue.This information was received from various sources.Both malfunctions had no reported patient involvement.The patients¿ age, weight, and sex were not provided for either malfunction.
Additional Manufacturer Narrative
The devices for the two malfunctions have been returned to the manufacturer for evaluation.One investigation unconfirmed the device marking issue.The investigation of the other malfunction is currently underway.The devices are 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.
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicated that model 47720 biopsy instrument allegedly experienced device markings issue.This information was received from various sources.Both malfunctions had no reported patient involvement.The patients¿ age, weight, and sex were not provided for either malfunction.
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicated that model 47720 biopsy instrument allegedly experienced device markings issue.This information was received from various sources.Both malfunctions had no reported patient involvement.The patients¿ age, weight, and sex were not provided for either malfunction.
Additional Manufacturer Narrative
H10: the lot number was provided and a lot history review was performed for two of the malfunctions.The devices for the two malfunctions were returned to the manufacturer for evaluation.The investigation for the two malfunctions was unconfirmed the device marking issue.Based upon the available information, the definitive root cause for this event is unknown.The devices are labeled for single use.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.

• Brand Name: GHIATAS LOCALIZATION WIRE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9572361
• Report Number: 2020394-2020-00183
• Device Sequence Number: 11251231
• Product Code: GDF
• UDI-Device Identifier: 00801741079818
• UDI-Public: (01)00801741079818
• 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,Followup
• Report Date (Section B): 06/26/2020

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: No Information
• Device Model Number: 47720
• Device Catalogue Number: 47720
• Device Lot Number: REDN4349,REDQ1624
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 03/24/2020; 06/26/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 03/25/2020; 06/26/2020
• Patient Sequence Number: 1