MAUDE Adverse Event Report: VYGON UMBILICAL CATHETER

Model Number 1270.03

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/25/2020

Event Type  Injury  

Manufacturer Narrative

The malfunctioning device will be returned to vygon for evaluation and investigation.The results of this investigation will be sent to fda in a follow-up mdr with in thirty days of its conclusion.The batch review does not shown any non-conformity.The device complies with iso 10555-1 standard.The tensile strength is higher than 10 newton which is the average minimum value.There are no other complaints in this batch.

Event Description

The serious adverse event occured the (b)(6) 2020.The umbilical catheter was inserted in a premature patient on (b)(6) 2020.No problem has been observed during the use period of 16 days.Tpn and other drugs were infused.During the removal of the catheter from the patient, the catheter was broken and some of it remained in the patient's body.The broken part was removed by surgical intervention.

Manufacturer Narrative

We received the involved umbilical catheter in two parts with its fixation patch.The fragment related to the distal end of the catheter was measured, it is 57 mm long.The microscopic examination shows an irregular cut with a smooth area on the fractured surface.This is characteristic of a cut with a sharp object, followed by an over stretch.The break is located close to the catheter fixation.No manufacturing related issues were identified during this investigation.From the description of the complaint the rupture occurred during its removal and it worked without any problems during the period of 16 days.The most likely root cause is an unintended cut and over stretch of the umbilical catheter during its removal.In the instructions of use, cautions for its "removal", are described as follows: "the catheter is removed by gente sustained traction closed to the exit site (2-3 cm).Do not over stretch the catheter".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 is higher than 10 newton which is the norm minimum value.There is no other complaint on this batch.No further corrective action initiated by quality management as there are no indications of a manufacturing fault.

Event Description

The serious adverse event occured the (b)(6) 2020.The umbilical catheter was inserted in a premature patient on (b)(6) 2020.No problem has been observed during the use period of 16 days.Tpn and other drugs were infused.During the removal of the catheter from the patient, the catheter was broken and some of it remained in the patient's body.The broken part was removed by surgical intervention.

• Brand Name: UMBILICAL CATHETER
• Type of Device: UMBILICAL CATHETER
• Manufacturer (Section D): VYGON; 5 rue adeline; ecouen 95440 ; FR 95440
• MDR Report Key: 10676817
• MDR Text Key: 211243279
• Report Number: 2245270-2020-00105
• 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,Followup
• Report Date: 01/07/2021

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 Operator: No Information
• Device Model Number: 1270.03
• Device Catalogue Number: 1270.03
• Device Lot Number: 260819PA
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 10/14/2020
• Supplement Dates Manufacturer Received: 09/25/2020
• Supplement Dates FDA Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention