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

Model Number	461043E
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported that a piece of the y-port connector on the iris feeding tubes broke off.No patient injury was reported.
Additional 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
• Common Device Name: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11127213
• Report Number: 1282497-2021-09835
• Device Sequence Number: 13622454
• Product Code: PIF
• UDI-Device Identifier: 20884521742199
• UDI-Public: 20884521742199
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 461043E
• Device Catalogue Number: 461043E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 01/11/2021
• Patient Sequence Number: 1