MAUDE Adverse Event Report: VYGON UMBILICAL CATHETER

Model Number 270.03

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 07/28/2021

Event Type  Death  

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 on the picture, we noticed the suture on the catheter, but the marking cannot be read, and the broken surface is not clear.We cannot see if the catheter has been damaged.The batch review does not show any non-conformity.The products are in conformity with the specifications.The device is compliant to norm iso 10555-1.The tensile strength measured values are all above the minimum value of iso norm, 10 newton.The tightness and the rounded tip of each umbilical catheter are controlled.There are no other complaints with this batch.The historical data analysis of the last 3 years regarding this product, shows that one catheter rupture occurred in 2019 during the dressing removal.The catheter was cut.No patient injury occurred.From this information, we cannot determine the cause of the rupture.It is well-known, that a premature baby of (b)(6) has a survival chance of 50%.There are many causes of death of a very large premature infant.

Event Description

A premature baby of (b)(6) and weighing (b)(6) is born at 0.39 am on (b)(6).An umbilical venous catheter was inserted at 1.00 am as central venous catheter for parenteral infusion and medication.Its correct placement and location have been checked by xr at 1.37 am.The catheter has been fixed by a suture.At 5.00 am the dressing has been changed because it was wet.The last control of the catheter and its insertion site was done at 6.00 am.7 hours after its insertion the catheter was found broken at some cm from its insertion.At 9.30 am the premature died.A picture of the broken catheter has been sent.

Manufacturer Narrative

We received the involved catheter in two parts.The proximal part with approx.5,5cm catheter's tube with its hub connected to a 3way stopcock, and the distal part of the catheter approx.30cm.We noticed a suture just after marking 5 until marking 8.The visual examination confirms the rouding of the distal part.The rupture is located far from the insertion site.Examination of the fracture surfaces of both parts, a rough and a smooth surface were identified, which is a typical sign when a sharp object has damaged/cut a part of the tube and then when a mechanical force is applied on the tube it causes the fracture.Therefore the root cause of the fracture is not a defect of the catheter.Furthermore, the last control of the catheter by the physician did not show any anomaly.The most likely cause of the rupture is traced to the user.The batch review does not shown any non-conformity.The products are in conformity with the specifications.The device is compliant to norm iso 10555-1.The tensile strength measured values are all above the minimum value of iso norm, 10 newton.The tightness and the roundingf tip of each umbilical catheter are controlled.There is no other complaint on this batch.The historical data analysis of the last 3-years on this product reference, shows that one catheter rupture occurred in 2019 during the dressing removal.No further corrective action will be initiated by quality management at this time as there are no indications of a manufacturing root cause.

Event Description

A premature baby of 24 weeks and weighing 710 g is born at 0.39 am on 28th july.An umbilical venous catheter was inserted at 1.00 am as central venous catheter for parenteral infusion and medication.Its correct placement and location have been checked by xr at 1.37 am.The catheter has been fixed by a suture.At 5.00 am the dressing has been changed because it was wet.The last control of the catheter and its insertion site was done at 6.00 am.7 hours after its insertion the catheter was found broken at some cm from its insertion.At 9.30 am the premature died.

• 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: 12312188
• MDR Text Key: 266174576
• Report Number: 2245270-2021-00099
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): Y
• Reporter Country Code: FR
• 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: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 270.03
• Device Catalogue Number: 270.03
• Device Lot Number: 301020PA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/28/2021
• Initial Date FDA Received: 08/12/2021
• Supplement Dates Manufacturer Received: 07/30/2021
• Supplement Dates FDA Received: 11/08/2021
• 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 Outcome(s): Death
• Patient Age: 24 WK