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

Catalog Number CDC-45703-XP1A

Device Problem Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 02/05/2022

Event Type  malfunction  

Event Description

Central line kits guidewire bending upon insertion.Fda safety report id # (b)(4).

Event Description

Central line kits guidewire bending upon insertion.Fda safety report id # (b)(4).

• Brand Name: CENTRAL LINE KIT
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): TELEFLEX MEDICAL
• MDR Report Key: 13534687
• MDR Text Key: 285647189
• Report Number: MW5107425
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDC-45703-XP1A
• Device Lot Number: 23F21K0120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other