MAUDE Adverse Event Report: COVIDIEN ENTFLX 12FR;36W/OSTYL W/Y PRT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884721211E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/11/2019
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 the enfit port on the nasogastric became loose causing leakage and removal.The nasogastric tube had to be replaced.
Additional Manufacturer Narrative
A review of the device history record could not be conducted because a lot number was not provided.A product analysis was unable to be completed as to date no samples have been provided.A photograph was submitted for evaluation.According to the photo, the issue was observed; the connector is detached.A connector detached may occur during the assembly process if an operator fails to complete the connector assembly.Precluding any further information or evidence there is not enough information at this time to determine with any confidence what likely caused the reported issue; therefore, the root cause is undetermined.Changes are made to support the validation of the solvent dispenser for the assembly of the y port.This change is to improve the manufacturing process and have a better control with the assembly process implementing a new solvent dispenser for a better handling of the solvent.

• Brand Name: ENTFLX 12FR;36W/OSTYL W/Y PRT
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125; cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 9088101
• Report Number: 9612030-2019-02267
• Device Sequence Number: 19537805
• Product Code: KNT
• UDI-Device Identifier: 10884521518896
• UDI-Public: 10884521518896
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2020

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: 8884721211E
• Device Catalogue Number: 8884721211E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/16/2019
• Supplement Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 09/19/2019
• Supplement Report FDA Received Date: 01/21/2020
• Patient Sequence Number: 1