MAUDE Adverse Event Report: VYGON UMBILICAL CATHETER; UMBILICAL CATHETER,

Model Number 1272.14

Device Problem Fluid/Blood Leak (1250)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/21/2018

Event Type  Injury  

Manufacturer Narrative

The results of this investigation are still pending, and will be communicated to fda within thirty days of its conclusion via follow-up mdr.

Event Description

Umbilical catheter inserted on (b)(6) 2018 15 :00 removed (b)(6) 2018 at 01 :15 tpn drained from abdomen, 80ml.

Manufacturer Narrative

100% control for tightness and non-obstruction is performed during the manufacturing process.A leaking catheter would have been rejected during this control.The root cause of these events cannot be defined.

Event Description

Umbilical catheter inserted on (b)(6) 2018 15 :00 removed (b)(6) 2018 at 01 :15 tpn drained from abdomen, 80ml.

• Brand Name: UMBILICAL CATHETER
• Type of Device: UMBILICAL CATHETER,
• Manufacturer (Section D): VYGON; 5 rue adeline; ecouen, 95440 ; FR 95440
• MDR Report Key: 7953287
• MDR Text Key: 123353937
• Report Number: 2245270-2018-00066
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• PMA/PMN Number: K981630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1272.14
• Date Manufacturer Received: 09/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 2 DA