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

Model Number IPN036445

Device Problems Material Deformation (2976); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/06/2022

Event Type  malfunction  

Event Description

Central line ballooned out while it was inserted in the patient.

• Brand Name: ARROW
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 15257924
• MDR Text Key: 298208532
• Report Number: 15257924
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10801902116793
• UDI-Public: (01)10801902116793
• 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: 08/11/2022

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
• Device Operator: Health Professional
• Device Model Number: IPN036445
• Device Catalogue Number: CDC-15703-P1A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/11/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/19/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14965 DA
• Patient Sex: Male
• Patient Weight: 79 KG