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

Model Number ASK-45703-PUPM1

Device Problems Output Problem (3005); Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Date 11/13/2021

Event Type  malfunction  

Event Description

Guidewire got stuck in the triple lumen catheter and would not tread.The guidewire was attempted to be removed from the catheter and the outer covering of the guidewire was uncoiled and stuck to the tlc.Fda safety report id # (b)(4).

• Brand Name: ARROW CENTAL LINE
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): TELEFLEX MEDICAL
• MDR Report Key: 12835690
• MDR Text Key: 281034366
• Report Number: MW5105436
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ASK-45703-PUPM1
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male