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

Model Number	461055E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that the ends (y-port) of the iris feeding tubes keep breaking.Some tubes are only lasting 2 days after placement into the patient.The customer believes this is due to the wire inside the tube not fitting with the peg ends and subsequently leaking.No patient injury was reported.New information received from the initial reporter on (b)(6) 2021 stated that the y-port at the end of the tubes split in the purple section between the two ports.This means the tubes leak, and can not be used.This seems to happen after 1-2 weeks of use.This is happening with a lot of tubes, to avoid having to replace the whole tube, they have cut the end of the tube off and inserted a standard replacement peg end.This allows them to continue using the tube.However the peg ends need repositioning every so often (cutting off a further 1-2cm of tube and reattaching the peg end), and they think this is because the tube can not mold properly to the peg end due to the internal wire (that powers the camera on the tip).This wire means the internal diameter of the tube is not completely circular, rendering the connection liable to leakage.

• Brand Name: 10FR 55 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: 11738214
• Report Number: 1282497-2021-10119
• Device Sequence Number: 19631323
• Product Code: PIF
• UDI-Device Identifier: 20884521742205
• UDI-Public: 20884521742205
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/28/2021

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 04/28/2021
• Patient Sequence Number: 1