MAUDE Adverse Event Report: VYGON UMBILICAL CATHETER

Model Number 270.04

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

Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 08/21/2019

Event Type  Injury  

Manufacturer Narrative

The malfunctioning device will be returned to vygon for evaluation as part of the complaint investigation.The results of this investigation are pending and will be communicated to fda within 30 days of its conclusion via follow up mdr.

Event Description

Antenatally diagnosed lumbosacral myeomeningocele.Operated on (b)(6) 2019.On the early hours of (b)(6) 2019 bleeding was noted around umbilical cord.Resident consultant examined and noted that there was bleeding originating from the catheter at the point of entry into the stump suggestive of break in the catheter.Uvc removed immediately to apply effective pressure.Tried to remove uac which snapped at the junction.Thus nearly 21 cm of catheter remained in situ.Bleeding controlled immediately with a metallic clamp.Surgical team informed.Parents consented for exploration and removal of arterial catheter.Catheter successfully removed in the pediatric surgical theatre.

• 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 lacroix ; 2750 morris road; lansdale, PA 19446 ; 8004735414
• MDR Report Key: 9097387
• MDR Text Key: 161435969
• Report Number: 2245270-2019-00056
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• PMA/PMN Number: K851005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 09/10/2019

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: 270.04
• Device Catalogue Number: 270.04
• Device Lot Number: 180718FQ
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/22/2019
• Initial Date FDA Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention