MAUDE Adverse Event Report: VYGON UMBILICAL CATHETER

Model Number 1270.03

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 10/15/2019

Event Type  Injury  

Manufacturer Narrative

The involved sample has not been kept.We received just a picture.We can notice on the picture that the line and its hub are separated.Without the sample, it is not possible to investigate in order to find the root cause of this incident.Furthermore, the information we received are not enough.We do not known how long the catheter was placed, how it was used and fixed.The batch review shows that this batch is compliant to the iso norm 10555-1.The tensile strength of the tube/hub is higher than 10 newton which is the norm minimum value.This is an isolated incident.There is no complaint on this batch and no similar incident this last 2 years.

Event Description

The umbilical catheter broke while in situ.The medical intervention was placing a new line.The patient should have suffered a line infection for which were given antibiotics no further information available concerning the patient outcome.

• 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: 9250643
• MDR Text Key: 164148575
• Report Number: 2245270-2019-00070
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• PMA/PMN Number: K921352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1270.03
• Device Catalogue Number: 1270.03
• Device Lot Number: 190719PA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/17/2019
• 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