MAUDE Adverse Event Report: VYGON UMBILICAL CATHETER

Model Number 1272.14

Device Problems Break (1069); Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/30/2020

Event Type  malfunction  

Manufacturer Narrative

The failed device was returned for evaluation as part of the complaint investigation.The results of this investigation are still pending, and will be reported to fda within thirty days of its conclusion via follow-up mdr.

Event Description

Catheter not intact.Removed with difficulty.Catheter broken at green colored hub.

Event Description

Catheter not intact.Removed with difficulty.Catheter broken at green colored hub.

Manufacturer Narrative

The complaint was forwarded to our parent company in france for their evaluation.The investigation summary is as follows: we received an umbilical catheter; a large amount of dried blood / drug is present in the catheter.The suture is wrapped around the tube at mark 10 indicates that the product was damaged during the dressing change.The tube is detached from the green hub.After cutting the green hub, the glue is visible on part of the periphery of the end.A review of the batch file did not reveal any anomalies during production on this batch.The tightness and non-tightness checks carried out at 100% meet our requirements.Tensile tests during production also meet our specifications.We have registered a similar complaint on this code also due to a tearing off.(defect related to the conditions of use).As the tube held for 4 days, we do not believe this is related to manufacturing defect therefore, no further corrective action is initiated by quality management.Corrective action: based on the investigation, this issue could not be traced to manufacturing defect; therefore, no further corrective action will be initiated at this time.This failure will be monitored for future actions.

Event Description

Catheter not intact.Removed with difficulty.Catheter broken at green colored hub.

Manufacturer Narrative

Correction: the 510k number should be k981630.The previous initial report mdr-2245270-2021-00014 listed k921352 erroroneously.

• Brand Name: UMBILICAL CATHETER
• Type of Device: UMBILICAL CATHETER
• Manufacturer (Section D): VYGON; 5 rue adeline; ecouen 95440 ; FR 95440
• MDR Report Key: 11338516
• MDR Text Key: 232598443
• Report Number: 2245270-2021-00014
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1272.14
• Device Catalogue Number: 1272.14
• Device Lot Number: 140819EJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Date Manufacturer Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 3