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

Model Number IPN911870

Device Problems Inadequacy of Device Shape and/or Size (1583); Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 10/18/2021

Event Type  malfunction  

Event Description

During central line insertion, trauma resident noted the guidewire for the 7french triple lumen catheter was too short.

• Brand Name: ARROW
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): TELEFLEX MEDICAL; po box 12600; durham NC 27709
• MDR Report Key: 13288714
• MDR Text Key: 284020795
• Report Number: 13288714
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: IPN911870
• Device Catalogue Number: ASK-42703-PLV
• Device Lot Number: 13F21G0121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/04/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1