MAUDE Adverse Event Report: COVIDIEN GIENTRI PORT WITH ENFIT CONNEC; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 771111E

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2020

Event Type  malfunction  

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.

Event Description

The customer reported that the sump bifurcated connector feeding device was leaking at the dial portion of the port.There was no harm to the patient.

Manufacturer Narrative

H 3 evaluation summary: a device history record (dhr) review could not be completed because the lot number was unavailable.The sample was received for evaluation.A leak in the received sample was not confirmed, however a missing component was detected in the anti-reflex valve (arv).The reported condition could not be confirmed.The root cause for the reported condition cannot be specifically identified; therefore, corrective action will be limited to manufacturing awareness at this time.The current 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.

• Brand Name: GIENTRI PORT WITH ENFIT CONNEC
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 9664763
• MDR Text Key: 177590181
• Report Number: 9612030-2020-02405
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 10884521582750
• UDI-Public: 10884521582750
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/02/2020

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: 771111E
• Device Catalogue Number: 771111E
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/23/2020
• Initial Date FDA Received: 02/04/2020
• Supplement Dates Manufacturer Received: 01/23/2020
• Supplement Dates FDA Received: 04/02/2020
• Patient Sequence Number: 1