MAUDE Adverse Event Report: COVIDIEN 3.5FR URETHANE UMB CATH; CATHETER, UMBILICAL ARTERY

Model Number 8888160333

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2020

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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported that the silicone tore/broke after placement.The catheter did not separate into two pieces.There was no patient harm.

Manufacturer Narrative

A review of the device history record revealed no discrepancies that may have contributed to the reported condition.All quality assurance testing is performed during the manufacturing of the product met specification requirements.Two used samples were received for analysis and investigation inside of its original package.A visual inspection of the sample revealed signs of use (blood).During the evaluation one of the catheters showed a leak below the strain relief.The event reported was confirmed.For these reasons the potential cause may be attributed to the manner of which the device was used including any form of repositioning or movement of the product.It is important to consider that the instructions for use warn: exercise caution when using sharp instruments near the catheter.Do not use instruments with sharp or rough edges directly on the catheter since even a minor cut could tear or break the catheter.Do not pinch or bend the catheter back to temporarily occlude the catheter.This causes increased stress on the catheter which can lead to a leak or break.Do not use clamps on umbilical vessel catheters] and continues, [do not use alcohol, acetone, or alcohol containing antiseptics directly on the catheter.Carefully check antiseptic solutions for alcohol or acetone.These substances may cause irreversible damage to the polyurethane which can lead to a leak or break.Ensure gloves or other surfaces which have alcohol on them are completely dry before touching or manipulating the catheter.In addition, the ifu states [the catheter lumen or catheter shaft should be flushed and filled with heparinized saline per hospital protocol.The catheter may be grasped with a smooth forceps or fingertips and inserted into the lumen of the dilated vessel.Catheter lumen should be occluded with saline via intermittent infusion caps or luer lock syringes during insertion to avoid air emboli.The reported complaint has not been confirmed as a manufacturing related issue.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: 3.5FR URETHANE UMB CATH
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN; edificio b20 calle #2 zona fra; alajuela ; CS
• MDR Report Key: 9664513
• MDR Text Key: 194120284
• Report Number: 3009211636-2020-00686
• Device Sequence Number: 1
• Product Code: FOS
• UDI-Device Identifier: 20884527005113
• UDI-Public: 20884527005113
• 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: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8888160333
• Device Catalogue Number: 8888160333
• Device Lot Number: 1916800093
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/29/2020
• Patient Sequence Number: 1