MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	IPN034625
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Cvc kit wire came apart (faulty wire frayed apart) when trying to remove wire from catheter in the patient that was in the proper place.

• Brand Name: ARROW
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 12091807
• Report Number: 12091807
• Device Sequence Number: 14597582
• Product Code: FOZ
• UDI-Device Identifier: 00801902071132
• UDI-Public: (01)00801902071132
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/22/2021
• Report Date (Section F): 06/22/2021

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: IPN034625
• Device Catalogue Number: ASK-15703-LDP1
• Device Lot Number: 13F20L0782
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 06/22/2021