MAUDE Adverse Event Report: COVIDIEN 5FR DUAL-LUMEN UVC CATH; CATHETER, UMBILICAL ARTERY

Model Number 8888160556

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/09/2018

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.

Event Description

The customer reported that the nurse practitioner was adjusting placement of an umbilical venous catheter and noticed that there was a drop of iv fluid escaping from the side of the umbilical catheter.The point where the fluid was leaking was close to where the line was sutured; the nurse practitioner noticed that the suture was quite tight.

Manufacturer Narrative

H 3: evaluation summary: because no lot number was available, a manufacturing device history record (dhr) review or product/process changes review for the involved lot number could not be performed.However, all dhrs are reviewed for accuracy prior to product release.One used catheter was received at the manufacturing site for analysis and investigation.Visual inspection of the sample presented signs of use.During the evaluation the catheter showed a leak below the strain relief.An underwater test was performed and a leak below the strain relief could be identified on the catheter.The reported condition has been confirmed.The most probable root cause can be considered as the catheter was most likely damage during use due to a sharp instrument or manipulation.It must be noted that in-process controls, such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling, are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.

• Brand Name: 5FR DUAL-LUMEN UVC CATH
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN; edificio b20 calle #2 zona fra; alajuela ; CS
• MDR Report Key: 9660891
• MDR Text Key: 194499794
• Report Number: 3009211636-2020-00685
• Device Sequence Number: 1
• Product Code: FOS
• UDI-Device Identifier: 20884527005182
• UDI-Public: 20884527005182
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8888160556
• Device Catalogue Number: 8888160556
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/29/2020
• Patient Sequence Number: 1