MAUDE Adverse Event Report: COVIDIEN 10FR 55 IRIS FEEDING TUBE ENF; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 461055E

Device Problem Material Twisted/Bent (2981)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the feeding tube had to be removed because it was kinked.There was no patient injury.

Manufacturer Narrative

Section b5 has been updated to include the following additional information provided by the customer: additional information provided by the customer on june 04, 2021 stated that the tube was in use for 6 weeks.It was initially post-pyloric but it moved back into the stomach.The provider attempted to reinsert the stylet to advance but could only get it in 60% of the way.She thought it was kinked but was not able to confirm that with an x-ray.The tube was patent as she was able to flush it.It was deemed to be kinked so she pulled it and replaced it.

Event Description

The customer reported that the tube had to be removed because it was kinked.There was no patient injury.Additional information provided by the customer on june 04, 2021 stated that the tube was in use for 6 weeks.It was initially post-pyloric but it moved back into the stomach.The provider attempted to reinsert the stylet to advance but could only get it in 60% of the way.She thought it was kinked but was not able to confirm that with an x-ray.The tube was patent as she was able to flush it.It was deemed to be kinked so she pulled it and replaced it.

Manufacturer Narrative

The device history record (dhr) could not be reviewed because there was no serial number provided by the customer.Samples were already used on a patient therefore it could not be taken to the production line for evaluation following customs policy.A sample evaluation is not able to be performed.A photograph of the part was provided however, kinked tubing was not observed on tube.Based on the problem described in the complaint, the tube has been in use for 6 weeks which exceeds the 28days defined in the instructions for use (ifu).A review of the manufacturing process of the y-port assembly, testing, inspection, packaging and raw materials showed no production issues that could cause the tube to kink.Based on the results of the investigation, the manufacturing process poses no risk to cause tubing to become kinked.The end user used the tube for 6 weeks, which exceeds 28days defined in the ifu.The supplier unable to determine a specific root cause.At this time no corrective actions are deemed necessary as there were no manufacturing related issues found.

• Brand Name: 10FR 55 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: 11895073
• MDR Text Key: 252972814
• Report Number: 1282497-2021-10227
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 20884521742205
• UDI-Public: 20884521742205
• 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,Followup
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 461055E
• Device Catalogue Number: 461055E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Date Manufacturer Received: 05/24/2021
• Patient Sequence Number: 1