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

Model Number	461055E
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
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
The customer reported that the patient was on continuous feed, the feeding was paused overnight and upon resuming it appeared to be clogged.There was no patient harm reported.
Additional Manufacturer Narrative
The device history record (dhr) for this device 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 received for evaluation however since the sample was already used on a patient, the device could not be taken to the production line for evaluation due to the current customs policy therefore a thorough sample analysis was not able to be performed.Instead, photographs of the affected device were reviewed but a root cause could not be determined due to limited information.The manufacturing site performed a feeding tube assembly process review.100% of the feeding tubes go through a leak test with pressure of 20±0.1psi per customer test specification.Any tube blockage failure would be detected and would be held in the manufacturing line.All tubes have 100% passed the leak test before package and shipment.From the investigation result, no abnormalities were found during the manufacturing process and there is no cause for a tube block/clogged in the manufacturing process.No action will be taken at this moment.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: 11826547
• Report Number: 1282497-2021-10194
• Device Sequence Number: 14510536
• Product Code: KNT
• UDI-Device Identifier: 10884521742208
• UDI-Public: 10884521742208
• 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): 08/13/2021

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
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 08/13/2021
• Patient Sequence Number: 1