MAUDE Adverse Event Report: COVIDIEN 10FR 55 IRIS FEEDING TUBE ENF; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	461055E
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
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. 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 tubing has a port that can become disconnected when in use.There is no way to secure the port (it is under a luer lock), thus tube feeding solution can end up not infusing into the patient.Once this port becomes disconnected, the pump will continue to pump formula all over the patient and the floor.The nurse has tried to tape the port shut to keep it from spilling, but it does not secure the tubing correctly.There was no patient harm reported.
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.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.Although a root cause could not be determined, 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 55 IRIS FEEDING TUBE ENF
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12197567
• Report Number: 1282497-2021-10500
• Device Sequence Number: 20045681
• Product Code: KNT
• UDI-Device Identifier: 20884521706139
• UDI-Public: 20884521706139
• 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: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 08/27/2021
• Patient Sequence Number: 1