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

Model Number IPN036855

Device Problems Material Frayed (1262); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 01/16/2022

Event Type  malfunction  

Event Description

The advanced practice provider (app) was placing a line for continuous renal replacement therapy (crrt).Ultrasound was used to find vessel, the guide wire was placed, needle removed, small incision made, and line was placed.While removing the guide wire it became what felt like "stuck".Upon removal the "hooked" part of the guide wire was frayed.

• Brand Name: ARROW
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 13927806
• MDR Text Key: 288026855
• Report Number: 13927806
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN036855
• Device Catalogue Number: AK-15123-F
• Device Lot Number: 13F21J0523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/22/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18980 DA
• Patient Sex: Male
• Patient Weight: 132 KG
• Patient Race: White