MAUDE Adverse Event Report: VYGON UMBILICAL CATHETER; UMBILICAL CATHETER,

Model Number 1270.03

Device Problems Fluid/Blood Leak (1250); Fracture (1260)

Patient Problem No Information (3190)

Event Date 03/11/2018

Event Type  malfunction  

Manufacturer Narrative

The malfunctioning device will be returned to vygon for evaluation as part of the complaint investigation.We have checked the history of complaints, no further complaints are registered on this batch.The batch review does not show any deviation or non-conformity.

Event Description

Nursing staff noted poor trace on uac - line flushed but problem persisted.Blood tracking back from patient despite heparinized saline running.Saw a fine jet saline coming from uac hub while flushing, crack noted.Had to clamp the catheter to prevent blood loss.This catheter was 5 days in place.The catheter is removed and replaced by an peripheral arterial line.Furthermore, no patient injury and no patient outcome have been reported.

Manufacturer Narrative

The device returned is attached to a 2ml luer slip syringe: the visual examination shows a crack in the catheter's hub see photo below.There is no obvious signs of moulding deformity or material weakness.Upon flushing the device , a leakage was identified from that crack: the most likely cause of that crack, is a mechanical stress apply to the hub.A manual over-tightening of the luer male of the connecting device into the female hub can creates hoop stress resulting in a fracture in the wall of the female luer.This event is not linked to a device defect.

• 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: 7380900
• MDR Text Key: 104036628
• Report Number: 2245270-2018-00014
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• PMA/PMN Number: K921352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: 1270.03
• Device Catalogue Number: 1270-03
• Device Lot Number: 031017EL
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2018
• 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