MAUDE Adverse Event Report: COVIDIEN 10FR 55 IRIS FEEDING TUBE ENF; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	461055E
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Customer reports; less than 48 hours after placement, the tube clogged.
Additional Manufacturer Narrative
The device history record (dhr) is established based on the serial number sticker located on the device packaging.Since the serial number was not provided, the dhr could not be reviewed.A sample was returned for evaluation however since the sample had been previously used on a patient, it could not be taken to the production line for testing and evaluation due to current custom policies.A picture of the feeding tube was provided for evaluation however the root cause could not be determined due to limited available information.It must be noted that 100% of the devices go through a leak test with pressure of 20±0.1psi per test specification.Any blockage failures would be detected and held at the manufacturing line.All tubes have 100% passed the leak test prior to being packaged and shipped.Based on the investigation, no abnormal issues were found during the manufacturing process and there is no further evidence indicating the failure is related to the manufacturing process.Based on the available information, a root cause could not be determined.No actions are required at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: 10FR 55 IRIS FEEDING TUBE ENF
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11752684
• Report Number: 1282497-2021-10137
• Device Sequence Number: 17185546
• Product Code: KNT
• UDI-Device Identifier: 20884521742205
• UDI-Public: 20884521742205
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/27/2021

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: 461055E
• Device Catalogue Number: 461055E
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 07/27/2021
• Patient Sequence Number: 1