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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2020

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

Customer reports that the device malfunctioned during use on a premature newborn baby.The device was working but "has stopped reading well" due to a leakage.On 1/8/2021 additional information states: the uac stopped reading well, so the line was inspected.Blood was noted to be backing up into catheter so all clamps were checked and verified fluid was infusing.The uac was flushed and noted there was a leak in the line where it connects to the hub.The uac was clamped below the leak, but per md had to be left in until off the ecmo circuit, which wasn't cut away until the end of the shift.This resulted in the loss of an arterial line for an ecmo trial and cut away, and left no drawable lines for gases resulting in pokes of a heparinized infant.

Manufacturer Narrative

A device history record review could not be performed because a lot number was not received with the complaint on january 28, 2021.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.One used sample with an unknown lot number was received at the manufacturing site for the investigation.The device showed signs of manipulation such as blue marks and glue on the tube which are not part of the finished product.Upon visual and functional evaluations, the reported issue was confirmed.The sample was submitted to an underwater leak test and a hole was observed below the strain relief.A definitive root cause could not be determined at this time.However, based on the available information, it can be concluded that the product was manufactured according to specifications.It must be noted that in-process controls such as personnel training, incoming quality acceptance testing for raw material, and 100% in process visual inspection and visual acceptance sampling are in place to prevent nonconforming product from leaving the manufacturing operations.100% pressure leak tests are executed per procedure using calibrated and validated instruments.The manufacturing operators that perform this operation are trained on the leak testing procedure.It is important to consider that the instructions for use warn: do not use a sharp clamp or instrument to handle the catheter since even a minor cut could tear or break the catheter.Do not stretch catheter.Too much tension could tear the catheter.Do not use alcohol or acetone-based skin preparations, adhesive enhancers, or solutions directly on the catheter.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 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: 11143328
• MDR Text Key: 226030823
• Report Number: 3009211636-2021-00732
• Device Sequence Number: 1
• Product Code: FOS
• UDI-Device Identifier: 20884527005120
• UDI-Public: 20884527005120
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• 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
• Date Manufacturer Received: 01/07/2021
• Patient Sequence Number: 1