MAUDE Adverse Event Report: COVIDIEN 5.0FR URETHANE UMB CATH; CATHETER, UMBILICAL ARTERY

Model Number 8888160341

Device Problem Fluid/Blood Leak (1250)

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

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 the umbilical artery catheter was placed by a nurse practitioner and a registered nurse (rn) connected fluids to the newly placed line.Shortly after initiating fluids, blood was noted to be backing up into the umbilical line.The rn noticed immediately and visualized a slow fluid leak from the umbilical catheter near the hub of the catheter.The line was clamped and the healthcare provider was notified.The line was removed and a new catheter was placed.

Manufacturer Narrative

A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.One sample was returned to the plant for the investigation.The sample arrived in a generic plastic bag.The catheter showed signs of use (residues of blood).A visual inspection was performed and a leak below the strain relief was identified.The reported issue was confirmed.A definitive root cause could not be determined at this time.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.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for qa tracking and trending purposes.

• Brand Name: 5.0FR URETHANE UMB CATH
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN; edificio b20 calle #2 zona fra; alajuela ; CS
• MDR Report Key: 8493092
• MDR Text Key: 141345135
• Report Number: 3009211636-2019-00654
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8888160341
• Device Catalogue Number: 8888160341
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/03/2019
• Initial Date FDA Received: 04/08/2019
• Supplement Dates Manufacturer Received: 04/03/2019
• Supplement Dates FDA Received: 08/05/2019
• Patient Sequence Number: 1