MAUDE Adverse Event Report: VYGON USA UMBILICAL CATHETER

Model Number 1272.14

Device Problems Break (1069); Material Split, Cut or Torn (4008)

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

Event Date 02/03/2023

Event Type  malfunction  

Manufacturer Narrative

The failed device will be returned to vygon for evaluation and complaint investigation.The results of this investigation are still pending,and will be communicated to fda within 30 days of its conclusion.

Event Description

Issue discovered during rn assessment.During assessment, uvc found to be severed at green plastic connector at bifurcation site of the two lumens.

Manufacturer Narrative

The complaint was forwarded to our parent company in france for their evaluation.The investigation summary is as follows: we received one sample for investigation.Analysis of the received sample shows that the tube is disconnected from the green central hub.We noticed the presence of residues in the tube and in the central hub at the bonding point.The tube is oval, which is characteristic of bonding in the hub the device was used for three (3) days before the incident occurred.Based on the sample received, we suspect that repeated traction in the tube is the cause of the separation.The diameter of the tube is correct.The origin of this defect is therefore linked to the conditions of use.We have received two complaints over the last 3 years for this defect.One without a sample classified as undetermined origin, and one linked to the conditions of use.A review of the lot history record could not be performed as the lot # was not supplied by the customer for this investigation.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.

Event Description

Issue discovered during rn assessment.During assessment, uvc found to be severed at green plastic connector at bifurcation site of the two lumens.

• Brand Name: UMBILICAL CATHETER
• Type of Device: UMBILICAL CATHETER
• Manufacturer (Section D): VYGON USA; 2750 morris road; lansdale PA 19446
• 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: 16486224
• MDR Text Key: 310716677
• Report Number: 2245270-2023-00014
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K981630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2023
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 5 DA