MAUDE Adverse Event Report: VYGON SA UMBILICAL CATHETER

Model Number 270.03

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

Vygon (b)(4) has done a visual examination of the returned catheter.The fracture section of the catheter has not been retained for investigation.The catheter has fractured between the 11 and 10 cm markers of the tube.No obvious signs of material weakness has been identified.The fracture surfaces were observed to be rough and uneven.These characteristics could be associated with the occurrence of a tensile fracture.Vygon(b)(4) did not received this sample and we have to confirm this first investigation.Furthermore , we have to verify that the suture has not caused this fracture.We have no further complaint on this batch.

Event Description

After insertion of an umbilical catheter , upon securing umbilical arterial catheter with suture, as per protocol the umbilical arterial catheter suddenly detached at 10,5 cm with 10,5 cm of line being retained within the patient.No scalpel or scissors were being used at the time the line fractured.The consultant attempted to secure the portion of line left inside the patient, but was unable to reach it.The baby remained clinically and haemodynamically stable.An urgent abdominal x-ray confirmed that the section of the line was present within the patient.The patient required surgical removal of the catheter by laparotomy.

• Brand Name: UMBILICAL CATHETER
• Type of Device: UMBILICAL CATHETER
• Manufacturer (Section D): VYGON SA; 5 rue adeline; ecouen, 95440 ; FR 95440
• Manufacturer (Section G): VYGON SA; 5 rue adeline; ecouen, 95440 ; FR 95440
• Manufacturer Contact: jillian mikovich ; 2750 morris road; lansdale, PA 19446 ; 8004735414
• MDR Report Key: 5634914
• MDR Text Key: 44551915
• Report Number: 2245270-2016-00028
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• PMA/PMN Number: K921374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 05/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 270.03
• Device Lot Number: 090315FQ
• Date Manufacturer Received: 04/08/2016
• 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