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	05/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported a broken iris tube at the hub; the connector piece detached.No patient injury was reported.
Additional Manufacturer Narrative
The device history record (dhr) could not be reviewed because there was no serial number provided by the customer.The y port tube is tracked by tube lot number, y port traceability could not be reviewed due to no tube lot number given.The investigation found that there were no related issues recorded throughout the manufacturing and control processes.The manufacturing records, including assembly, test, inspection and packaging, no risk cause y port detach.All tubes have been 100% tested by leak test station follow customer specification of air pressure 20psi.Any of leakage issue could be detected if y port detached.All tubes have been 100% inspected before packaging.Also, each lot is released based on an acceptable quality limit (aql) inspection.The product was in conformance to specifications and was released for distribution meeting all established quality assurance acceptance levels.The device was not returned for evaluation however one photograph was submitted for evaluation.The photo confirms that there is a detached y-port connector which is assembled by a supplier.A review of the manufacturing and quality process controls for this product was conducted by the supplier and the feedback provided was that they unable to determine the root cause without the physical sample to evaluate.Corrective actions have been taken for the detached component by installing a new solvent dispenser for a better handling of the solvent during the assembly process of the y-port.Additionally, to improve the structure of the y-port design it was changed from a ¿wing¿ design to ¿no-wing¿ design, because a ¿no-wing¿ design will increase the surface area of the bond and it has proven to increase the bond strength of the y-port assembly.The validation of this change is planned to be completed within the next two months.

• 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: 11936095
• Report Number: 1282497-2021-10239
• Device Sequence Number: 4226982
• Product Code: PIF
• UDI-Device Identifier: 20884521742199
• UDI-Public: 20884521742199
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 08/16/2021

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: 05/12/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 08/16/2021
• Patient Sequence Number: 1