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

Model Number	771111E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2020
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.
Event or Problem 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.
Additional 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
• 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: 9664763
• Report Number: 9612030-2020-02405
• Device Sequence Number: 2756740
• Product Code: PIF
• UDI-Device Identifier: 10884521582750
• UDI-Public: 10884521582750
• 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,Followup
• Report Date (Section B): 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
• Operator of Device: No Information
• Device Model Number: 771111E
• Device Catalogue Number: 771111E
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 04/02/2020
• Patient Sequence Number: 1