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

Model Number 8888160333

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2020

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 the device is leaking at the joint.There was no harm to the patient.

Manufacturer Narrative

A device history review (dhr) revealed no discrepancies that may have contributed to the reported issue.All quality assurance testing performed during manufacturing was acceptable.The quality assurance review of the visual, physical, and dimensional evaluation results indicated that the product met specification requirements.In addition, all dhr are reviewed for accuracy prior to product release.One photo was provided by the customer for analysis and investigation.According to the visual inspection of the photo, the catheter was used as blood was observed on the catheter.Blood was also observed coming out near the ¿y¿ junction.The reported issue of leaking was confirmed.Based on all available information, it can be concluded that the product was manufactured according to specifications.Therefore the most probable root cause is that the leak was caused by damage while in use.It¿s important to consider that the instructions for use state: do not use 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.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: 10581296
• MDR Text Key: 208382615
• Report Number: 3009211636-2020-00717
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• 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: 1915800078
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/17/2020
• Patient Sequence Number: 1