MAUDE Adverse Event Report: COVIDIEN ENTRFLX 10FR;43IN W/STY YPORT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884721088E

Device Problem Disconnection (1171)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/19/2019

Event Type  malfunction  

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 Description

The customer reported that the patients nasogastric tube had been in for 9 days.The nursing staff went to flush and the end snapped off at one of the connection points.

Manufacturer Narrative

A review of the device history record showed no manufacturing was not completed as the lot number was unknown.A photograph was submitted for evaluation.Based solely on the photograph, it is not possible to confirm the reported condition.A product analysis was unable to be completed as to date no samples have been provided.However, based on the description of the incident as reported by our customer the most likely root cause for a connector leaking is a workmanship issue when an operator fails to complete an assembly or following the predetermined process steps to assure a complete assembly.Changes have been 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 to have better control of the process assembly, implementing a new solvent dispenser for a better handling of the solvent.

• Brand Name: ENTRFLX 10FR;43IN W/STY YPORT
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 9516319
• MDR Text Key: 172703359
• Report Number: 9612030-2019-02383
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521582996
• UDI-Public: 10884521582996
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/25/2020

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
• Device Operator: No Information
• Device Model Number: 8884721088E
• Device Catalogue Number: 8884721088E
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/19/2019
• Initial Date FDA Received: 12/24/2019
• Supplement Dates Manufacturer Received: 12/19/2019
• Supplement Dates FDA Received: 02/26/2020
• Patient Sequence Number: 1