MAUDE Adverse Event Report: VYGON UMBILICAL CATHETER,

Model Number 1272.14

Device Problems Fluid/Blood Leak (1250); Patient Device Interaction Problem (4001)

Patient Problem Extravasation (1842)

Event Date 02/26/2019

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 investigation can be done.

Event Description

The event occured (b)(6) 2019 on a preterm infant (b)(6).The device stays 3 days in the patient.The preterm infant had an extravasation of tpn fluid in liver and right pleural space leading to chest drain insertion.The device has been removed and chest drain inserted.No injury occured, patient gone home.

• 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: 8641347
• MDR Text Key: 146095156
• Report Number: 2245270-2019-00027
• 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: 05/15/2019

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
• 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