MAUDE Adverse Event Report: COVIDIEN 16FR SALEM W/ GIENTRI PORT WIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	7771610E
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/25/2020
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 tip of the feeding tube formed a "c" shape and seemed to kink on itself.They tried to administer feed, but it would not go through.They removed the device and replaced it with a feeding tube from another manufacturer.There was no patient injury.

• Brand Name: 16FR SALEM W/ GIENTRI PORT WIT
• Common Device Name: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 9779927
• Report Number: 9612030-2020-02430
• Device Sequence Number: 11425583
• Product Code: PIF
• UDI-Device Identifier: 10884521582736
• UDI-Public: 10884521582736
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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
• Report Date (Section B): 03/03/2020

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: 7771610E
• Device Catalogue Number: 7771610E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 03/03/2020
• Patient Sequence Number: 1