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

Model Number	47720
Medical Device Problem Codes	Nonstandard Device (1420); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported event, lot number was provided, and lot history review.The sample was returned for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 47720.Biopsy instrument allegedly device contamination with chemical or other material.This report was received from a single source.This event did not involve patient with no reported patient contact.The patient age, gender and weight was not provided.
Additional Manufacturer Narrative
H10: for the reported event, lot number was provided, and lot history review.The sample was returned for evaluation.After further evaluation, it was identified that foreign material was present on the cannula.Based upon the available information, the definitive root cause for this event is unknown.The device is 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.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 47720 biopsy instrument allegedly was contaminated with chemical or other material.This report was received from a single source.This malfunction did not involve a patient as there was no patient contact.The patient age, gender and weight was not provided.
Additional Manufacturer Narrative
H10: for the reported event, lot number was provided, and lot history review.The sample was returned for evaluation.After further evaluation, it was confirmed that foreign material was present on the cannula.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H10: g4, h11: b5, h6 (results, conclusion) 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
This report summarizes one malfunction.A review of the reported information indicated that model 47720 biopsy instrument allegedly was found to be nonstandard device.This report was received from a single source.This malfunction did not involve a patient as there was no patient contact.The patient age, gender and weight was not provided.

• 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: 9198940
• Report Number: 2020394-2019-04017
• Device Sequence Number: 16901825
• 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): 07/10/2020

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: RECT0522
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 12/31/2019; 06/29/2020
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 01/06/2020; 07/10/2020
• Patient Sequence Number: 1