MAUDE Adverse Event Report: COVIDIEN 10FR 43 IRIS FEEDING TUBE ENF; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 461043E

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/12/2021

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported a broken (detached) iris tube at the hub.No patient injury was reported.No additional information available.

Manufacturer Narrative

A device history record review could not be performed because the lot and serial numbers were not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.A sample was not received for the investigation.However, a photo was provided.The photo was reviewed, and the reported issue was confirmed; a detached component was observed.A root cause analysis indicated that this condition occurred as a result of a workmanship issue.As part of continuous improvements, a corrective action has been opened to address this condition.A new solvent dispenser was implemented for a better handling of the solvent during the assembly process of the y-port.This complaint will be used for tracking and trending purposes.

• Brand Name: 10FR 43 IRIS FEEDING TUBE ENF
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11979217
• MDR Text Key: 255983652
• Report Number: 1282497-2021-10246
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 20884521742199
• UDI-Public: 20884521742199
• 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: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 461043E
• Device Catalogue Number: 461043E
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/12/2021
• Patient Sequence Number: 1