MAUDE Adverse Event Report: VYGON UMBILICAL CATHETER

Model Number 1270.03

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem Fluid Discharge (2686)

Event Date 11/02/2021

Event Type  Injury  

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.The batch review of these devices is compliant.No deviation has been registered.These umbilical catheters are conform to iso 10555-1 norm.During the manufacturing process, a tightness test is performed on each catheter prior its packaging.All tensile strength measures are above 10 n, the minimum value of iso norm.The analysis of the history of complaints and incidents shows that this is the first complaint on this batch.Furthermore, the umbilical catheter has probably been flushed prior its insertion to the patient by the user, and the leakage through the hole should have been noticed.

Event Description

The catheter was in place for a good 96 hours, discovered during a routine check.The catheter had to be removed and another central catheter placed as an emergency.With a child weighing 600g it is a very big stress and risk.The patient lost fluids (proteins, carbohydrates) continuously through the catheter, blood could also be aspirated, which leaked out.

Manufacturer Narrative

We received the involved umbilical catheter and 2 samples from same batch returned from user.The investigation confirms a hole on the catheter's tube between marking 5 and 6.A leakage was identified during the tightness test under 500 mbar air pressure.Under microscopic examination, the shape of the identified hole is characteristic of the destruction of the tube by a sharp object.From the description of the incident, the catheter was functioning correctly for 96 hours.We do not know how the catheter was handled, how the refection of dressing was done etc.Both samples from the same batch were compliant, no leakage and no holes.Both umbilical catheters are compliant.With the specification.The batch record review shows that all products are in compliance with the specification and iso norm.There is no nonconformity or deviation.Furthermore, the historical data analysis over the last 3 years, shows that this is the first incident reported for this batch and there is no similar incident on this product.The root cause of this incident is not due to a catheter quality defect but traced the user.In the product ifu there is a warning as follows: "do not apply sharp or rough-edged instruments directly to the catheter: even a minor cut could tear it or break it.Do not deliberately cut the catheter." no further corrective action initiated by quality management as there are no indications of a manufacturing fault.

Event Description

Fluid came out of the hole between mark 6-7.The catheter was in place for a good 96 hours, discovered during a routine check.The catheter had to be removed and another central catheter placed as an emergency.With a child weighing 600g it is a very big stress and risk.The patient lost fluids (proteins, carbohydrates) continuously through the catheter, blood could also be aspirated, which leaked out.

• 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 o lacroix ; 2750 morris road; lansdale, PA 19446 ; 8004735414
• MDR Report Key: 12983717
• MDR Text Key: 283249471
• Report Number: 2245270-2021-00129
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K921352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1270.03
• Device Catalogue Number: 1270.03
• Device Lot Number: 061120PB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2021
• 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 Weight: 1 KG