MAUDE Adverse Event Report: VYGON UMBILICAL CATHETER

Model Number 1272.14

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Liver Contusion (1953); Liver Laceration(s) (1955)

Event Date 02/01/2019

Event Type  Injury  

Manufacturer Narrative

As batch is unknown, no review can be done.All umbilical catheters are 100% tested for tightness and non-obstruction during the manufacturing process.The sample has not been retained.No further investigation can be done.

Event Description

The event occured (b)(6) 2019 on a preterm infant (b)(6).The device was in until day 8 of baby's life.Liver injury following the use of the umbilical catheter.It is likely to be a liver haematoma but cannot exclude tpn/blood extravasation.The device has been removed.

• Brand Name: UMBILICAL CATHETER
• Type of Device: UMBILICAL CATHETER
• Manufacturer (Section D): VYGON; 5 rue adeline; ecouen, 95440 ; FR 95440
• Manufacturer (Section G): VYGON; 5 rue adeline; ecouen, 95440 ; FR 95440
• Manufacturer Contact: freda lacroix ; 2750 morris road; lansdale, PA 19446 ; 8004735414
• MDR Report Key: 8641350
• MDR Text Key: 146095297
• Report Number: 2245270-2019-00028
• 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
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1272.14
• Device Catalogue Number: 1272.14
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/10/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention