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

Model Number	UCTW17
Medical Device Problem Codes	Material Discolored (1170); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review was performed.The sample was not returned to the manufacturer for evaluation but received two electronic photographs.Therefore, the investigation of the reported event is confirmed for the alleged bend and material discoloration.Based upon the available information, the definitive root cause for this event is unknown.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 uctw17 biopsy instrument allegedly experienced bent needle.This information was received from one source.This event did involve patient with no reported patient contact.The patient's age and weight was not provided.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a manufacturing review was performed.The sample was not returned to the manufacturer for evaluation but received two electronic photographs.Therefore, the investigation of the reported event is confirmed for the alleged bend and material discoloration.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H11: d3.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 uctw17 biopsy instrument allegedly experienced bent needle.This information was received from one source.This event did involve patient with no reported patient contact.The patient's age and weight was not provided.

• Brand Name: ULTRACOR TWIRL MARKER
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10282990
• Report Number: 2020394-2020-04497
• Device Sequence Number: 2864687
• 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): 07/20/2020

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: HUBZ1177
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 07/20/2020
• Patient Sequence Number: 1