MAUDE Adverse Event Report: COVIDIEN 12FR 43 IRIS FEEDING TUBE ENF; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 461243E

Device Problem Fracture (1260)

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

Event Date 04/19/2021

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 that the nj tube cracked at the enfit port.There was no patient injury.

Manufacturer Narrative

A device history record review could not be performed because the lot and serial numbers were not received with the complaint.However, as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.One physical sample was received at our decontamination lab for the investigation.However, the used sample cannot be forwarded to the manufacturing site for physical evaluation at this time due to current customs policies.As a result, photos were taken of the sample that was received at our decontamination lab and were shared with the manufacturing site to aid the investigation.Upon a visual evaluation of the photos, the reported issue could not be confirmed as a crack was not observed in the photos.The manufacturing process, including the assembly, tests, inspections, and packaging of the product was reviewed.There have been no y-port cracks detected on the production line and all test performed have passed.If the sample is received at the manufacturing site at a later date, the investigation will be updated accordingly.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: 12FR 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: 12032631
• MDR Text Key: 257268390
• Report Number: 1282497-2021-10304
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 20884521742229
• UDI-Public: 20884521742229
• 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: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 461243E
• Device Catalogue Number: 461243E
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/14/2021
• Patient Sequence Number: 1