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

Model Number	UCTW17
Medical Device Problem Codes	Material Discolored (1170); Device Contamination with Chemical or Other Material (2944); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates that model uctw17, breast tissue marker, allegedly experienced bent material, and foreign material present in the device.This information was received from a single source.This malfunction did not involve a patient, therefore patient details were not provided.
Additional Manufacturer Narrative
H10: the lot number was provided and a lot history review was performed.The sample was returned to the manufacturer for inspection/evaluation.The investigation is confirmed for the bent and material discolored.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 indicates that model uctw17, breast tissue marker, allegedly experienced bent material, and foreign material present in the device.This information was recieved from a single source.This malfunction did not involve a patient.The device was used in a female patient, however age, and weight details was not provided.

• Brand Name: ULTRACOR TWIRL MARKER
• Common Device Name: BREAST TISSUE MARKER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9957865
• Report Number: 2020394-2020-02660
• Device Sequence Number: 2437669
• Product Code: NEU
• UDI-Device Identifier: 00801741109416
• UDI-Public: (01)00801741109416
• 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): 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: UCTW17
• Device Catalogue Number: UCTW17
• Device Lot Number: HUDR2426
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 06/26/2020
• Patient Sequence Number: 1