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

Model Number	461043E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2021
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.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported that one of the two luer lock ports broke, causing leaking and issues with the ng tube.The other valve was not broken but unable to give feedings with the other port de to loss in pressure.When attaching the tube feeding to the port you cannot tighten too tight or it can cause this issue of the port breaking.There was no patient injury.
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.
Additional Manufacturer Narrative
The device history record (dhr) is established based on the serial number sticker on the device package.A serial number was not provided, therefore the dhr could not be reviewed.As part of the manufacturing process, all dhrs are reviewed and approved by quality, prior to release of the product.Since a sample was not returned for evaluation and no photos were provided, a product failure analysis could not be performed, and a root cause of the reported issue was unable to be determined.The manufacturing process of the y-port assembly, tests and inspections were reviewed.All devices are 100% tested and inspected prior to release.Although the root cause of the reported issue was not be determined, corrective actions were recently implemented; a new solvent dispenser was put into service, and the structure of the y-port design change has been made from the wing design to a no-wing design because the no-wing design will increase the surface area of the bond and has been proven to increase the bond strength of the y-port assembly.Functional testing and visual inspections are being performed according to the current quality standards and inspection procedures.If a sample is received, this complaint will be reopened for further investigation.This complaint will be used for qa tracking and trending purposes.

• 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: 11740047
• Report Number: 1282497-2021-10122
• Device Sequence Number: 3104771
• Product Code: PIF
• UDI-Device Identifier: 20884521742199
• UDI-Public: 20884521742199
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Followup
• Report Date (Section B): 07/12/2021

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: 1043060119
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 04/14/2021; 04/14/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 04/28/2021; 07/12/2021
• Patient Sequence Number: 1