MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. GEL MARK ULTRACOR BIOPSY SITE MARKER

Model Number	GMUEC7GSS
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes one malfunction event.A review of the event indicated that model gmue7gss gel mark ultracor biopsy site marker experienced detachment of device.For this event, the device was used on the patient with no reported injury.The patient¿s age, sex, and weight were not provided.The gmue7gss gel mark ultracor biopsy site marker was not returned for evaluation, limiting investigation.
Event or Problem Description
This report summarizes one malfunction event.A review of the event indicated that model gmue7gss gel mark ultracor biopsy site marker experienced detachment of device.For this event, the device was used on the patient with no reported injury.The patient¿s age, sex, and weight were not provided.
Additional Manufacturer Narrative
The device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.The physical sample was not returned for evaluation.One electronic photo was provided for review.Based on the photo review, one distal portion of the marker applicator noted to be laying on a flat surface, bloody with one "omega" shaped wireform present within the aperture.No marker pads were visible within the photo.The distal portion noted to have a jagged break and stretching to the proximal end.Therefore, based on the photo review, the investigation is confirmed for the alleged detached distal tip of the marker applicator.Although it is highly likely procedural factors contributed to the reported event, the definitive root cause for the reported applicator tip detachment could not be determined based on the provided limited information.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: GEL MARK ULTRACOR BIOPSY SITE MARKER
• Common Device Name: BIOPSY SITE MARKER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8525353
• Report Number: 2020394-2019-00478
• Device Sequence Number: 1966017
• Product Code: NEU
• UDI-Device Identifier: 00801741031861
• UDI-Public: (01)00801741031861
• 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): 07/25/2019

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: GMUEC7GSS
• Device Catalogue Number: GMUEC7GSS
• Device Lot Number: VTCP00055
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 07/25/2019
• Patient Sequence Number: 1