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

Model Number CDC-45703-XP1A

Device Problems Material Deformation (2976); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 03/18/2022

Event Type  malfunction  

Event Description

Central line guidewire unfurled during the procedure inside the patient.

• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): ARROW INTERNATIONAL, LLC; po box 12600; durham NC 27709
• MDR Report Key: 14235549
• MDR Text Key: 290275781
• Report Number: 14235549
• 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: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CDC-45703-XP1A
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/26/2022
• Date Report to Manufacturer: 04/28/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20440 DA
• Patient Sex: Female