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

Model Number	8884721211E
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2019
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 over the last 6 months the kangaroo nasogastric tubes have been breaking, especially with extended use greater than 1 week.The customer further reported that they are splitting at the join between the enfit port and at the side of the medication port.It was also noted that there was leaking at the enit to the pump set connector and the enfit port is also breaking during use.
Additional Manufacturer Narrative
The device history record (dhr) file was reviewed indicating that product was released meeting all quality standard requirements.Two samples were received for evaluation.After performing an inspection per procedure; the reported condition was not observed with the samples received.The received samples met specifications.The condition reported was not observed in the product; therefore, the root cause was not identified.A review of the process also did not determine a root cause.No corrective actions are deemed necessary at this moment.The process is running according to product specifications meeting quality acceptance criteria.The manufacturing site will continue monitoring the process for any adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.
Additional Manufacturer Narrative
Added the initial reporter's phone number.

• 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: 9125643
• Report Number: 9612030-2019-02294
• Device Sequence Number: 2332702
• Product Code: KNT
• UDI-Device Identifier: 10884521583016
• UDI-Public: 10884521583016
• 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,Followup
• Report Date (Section B): 12/09/2019

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
• Device Lot Number: 1828101864
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 09/17/2019; 09/17/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 09/30/2019; 12/09/2019
• Patient Sequence Number: 1