MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. USHER SUPPORT CATHETER

Model Number	USH130T
Medical Device Problem Code	Insufficient Device Problem Information (3190)
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 will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date 01/2018).
Event or Problem Description
It was reported that an alleged potential counterfeit product was identified at the customer facility.It was further reported that the supplier of the device is not an authorized distributor.There was no reported patient contact.

• Brand Name: USHER SUPPORT CATHETER
• Common Device Name: SUPPORT CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9153149
• Report Number: 2020394-2019-03712
• Device Sequence Number: 2576490
• Product Code: DQY
• UDI-Device Identifier: 00801741068034
• UDI-Public: (01)00801741068034
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K131493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/03/2019

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: Health Professional
• Device Model Number: USH130T
• Device Catalogue Number: USH130T
• Device Lot Number: GFYL2072
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1