MAUDE Adverse Event Report: COVIDIEN 10FR 43 IRIS FEEDING TUBE ENF; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	461043E
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2021
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.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.  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 iris feeding tube was placed on (b)(6) 2021 and broke on (b)(6), 2021.A photo was provided and shows that the y-port cracked and a portion of it broke off.There was no patient injury.
Additional Manufacturer Narrative
A photograph of the device was provided, and a crack is seen on the y-port.The root cause could not be determined based solely on a photographic evaluation.The manufacturing process of the y-port assembly, tests and inspections were reviewed.They performed leak test following all product specifications.Functional testing and visual inspections are being performed according to the current quality standards and inspection procedures.The analysis performed by the team concluded that the main root cause is related to a workmanship issue for the detached connector.Corrective actions were implemented by installing a new solvent dispenser for a better handling of solvent for the assembly process of the y-port and to improve the structure of the y-port design by eliminating the ¿wing¿ design and replacing it with a ¿no wing¿ design which will increase the surface area of the bond strength for the y-port assembly.

• 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: 12032207
• Report Number: 1282497-2021-10300
• Device Sequence Number: 4765614
• 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): 09/08/2021

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
• Device Lot Number: 1043100120
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 09/08/2021
• Patient Sequence Number: 1