MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRACOR BREAST TISSUE MARKER; BIOPSY INSTRUMENT

Model Number	UCTC17GSS
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation, however mri images were received, therefore 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 (1) malfunction event.A review of the event indicated that model uctc17gss biopsy instrument appeared to be larger than other devices of the same type under mri.This event was reported from a single source.This event involved a patient with no reported injury.The patient¿s age, weight, and sex were not provided.
Event or Problem Description
This report summarizes one (1) malfunction.A review of the reported information indicated that model: uctc17gss biopsy instrument appeared to be larger than other devices of the same type under mri.This malfunction was reported from a single source.This malfunction involved a patient with no reported injury.The patient¿s age, weight, and sex were not provided.
Additional Manufacturer Narrative
H10: the device has not been returned for evaluation, however mri images were received; review of the images by a medical professional indicated that the amount of blooming artifact given by the device is normal.The device is labeled for single use.H10: g4: pma/510k.H11: b5: event, 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.

• Brand Name: ULTRACOR BREAST TISSUE MARKER
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8525184
• Report Number: 2020394-2019-00457
• Device Sequence Number: 19550484
• Product Code: FZP
• UDI-Device Identifier: 00801741032202
• UDI-Public: (01)00801741032202
• 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): 10/09/2019

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: UCTC17GSS
• Device Catalogue Number: UCTC17GSS
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 10/11/2019
• Patient Sequence Number: 1