MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW MULTI-LUMEN CENTRAL VENOUS CATHETERIZATION KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Catalog Number CDC-42703-XP1A

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 03/02/2022

Event Type  malfunction  

Event Description

Proximal lumen cut by the blue clamp.

• Brand Name: ARROW MULTI-LUMEN CENTRAL VENOUS CATHETERIZATION KIT
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 13794777
• MDR Text Key: 287332322
• Report Number: 13794777
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/10/2022,03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CDC-42703-XP1A
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/10/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Weight: 81 KG