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

Model Number 461055E

Device Problems Fluid/Blood Leak (1250); Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported the tube clogged and the seal around the port leaked.There was no harm to the patient.

Manufacturer Narrative

H3 evaluation summary: the device history record (dhr) was not able to be reviewed because the lot number was not available.The manufacturing site reviewed their manufacturing process including assembly, testing, inspection and packaging, and no risk was found that would cause the y-port to be broken or cracked.All tubes have been 100% tested by the leak test station following specification.The leak test includes occlusion testing and a vacuum test.Any problem of leakage or occlusion would be detected during testing.The stylet can¿t be inserted into feed-tube at the stylet insertion station if the tube is occluded.All tubes have been 100% inspected before packaging.The sample was shipped to the supplier for investigation.A slight separation is observed between the male connector and the y-port connector.When tested in a functional way, the connector presented a leak between both components.The sample does not appear to show solvent residue, thus confirming the reported issue of leaking.Regarding the occlusion, no obstruction was observed in the evaluated sample.It was tested and there was water flow, so the issue of occluded is not confirmed.The analysis performed by the team concluded that the main root cause is a workmanship issue.The reported condition could be generated when an operator fails to complete an assembly or by not following the predetermined process steps to assure a complete assembly.No obstruction was observed in the evaluated sample.The leak test and stylet insertion station would detect an occlusion issue.The correction and prevention actions (capa) are to have an automated solvent dispenser introduced to the assembly process for joining the enfit connector to the y-port body.The automated solvent dispenser will replace the current solvent dispenser for the enfit y-port, which is not automated and requires an operator to dip the rigid enfit connector into a bowl of solvent.The automated solvent dispenser will eliminate complexities of the current system to guarantee a consistent amount of solvent is applied to the enfit connector.The design and assembly process of the enfit y-port assembly will be modified.This modification will change from a winged enfit connector and y-port body design to a no-wing design.This complaint will be used for tracking and trending purposes.

• Brand Name: 10FR 55 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: 12377563
• MDR Text Key: 268472702
• Report Number: 1282497-2021-10575
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 20884521742205
• UDI-Public: 20884521742205
• 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: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 461055E
• Device Catalogue Number: 461055E
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/20/2021
• Patient Sequence Number: 1