MAUDE Adverse Event Report: VYGON UMBILICAL CATHETER

Model Number 1270.05

Device Problem Migration (4003)

Patient Problems Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 07/31/2019

Event Type  Injury  

Manufacturer Narrative

The failed sample will be returned to vygon for device evaluation as part of the complaint investigation.The results of this investigation are still pending,and will be communicated to fda within 30 days of its conclusion.All umbilical catheters are 100% tested for tightness and non-obstruction during the manufacturing process.No other complaint has been registered on the possible listed batches.

Event Description

A cardiac arrest on tamponade (pericardial effusion) occured the (b)(6) 2019 , on a preterm baby.Possible batch: 240519pa, 200418al, 220519pa or 191018al.No further information available concerning the patient outcome.

Manufacturer Narrative

We received the involved catheter.The tube has been cut at 15mm before the marking of 4 cm.We noticed that the catheter shows clearly signs of cut and torn, characteristic of a cut made by a sharp object.It occurs probably during the patient placement.The 3 possible batches are compliant to the specifications.We registered no similar complaint on these 3 possible batches.

Event Description

A cardiac arrest on tamponade (pericardial effusion) occured the (b)(6) 2019 , on a preterm baby.Possible batch 240519pa ,200418al ,220519pa or 191018al.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
• MDR Report Key: 8894428
• MDR Text Key: 155348662
• Report Number: 2245270-2019-00053
• 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,Followup
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1270.05
• Device Catalogue Number: 1270.05
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1