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 12/10/2020

Event Type  malfunction  

Manufacturer Narrative

The device history record could not be reviewed as the lot number or serial number were not provided.A sample was not returned for evaluation therefore a failure analysis could not be performed.A picture of the reported issue was provided however the root cause could not be determined based on the evaluation of the picture.According to the supplier, all feeding tubes are 100% tested and inspected during the manufacturing process.The feeding tubes cannot be packaged if they fail at any station.The leak test station can detect any y-port assembly issues including leaking and broken components.No assembly issues were found in the past 12 months.The fni station pulls and inspects the y-port assembly quality and there were no y-port drop off issues found on the production line.The supplier reviewed the raw material performance.38,000 pieces of the y-port were assembled on the production line in past 12 months and no y-port crack issue were found.From the investigation, no abnormal displays were found during the manufacturing process and the reported failure was not found on the raw components therefore a root cause could not be determined.Functional testing and visual inspections are being performed according to current quality standards and inspection procedures.If the physical sample is received at a later date, this complaint will be reopened for further investigation.This complaint will be used for tracking and trending purposes.

Event Description

The customer reported that a piece of the y-port connector on the iris feeding tubes broke off.No patient injury was reported.

Manufacturer Narrative

Based on additional information received on 11-jan-2021, section e1 was updated with the initial reporter's first name, last name and email.

• 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: 11127213
• MDR Text Key: 230949703
• Report Number: 1282497-2021-09835
• 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: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• 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: 12/11/2020
• Patient Sequence Number: 1