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

Model Number	8884721088E
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2019
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.
Event or Problem Description
The customer reported that the ng tube had a split at the bifurcation.Additional information received from the customer stated that the tube was broken at the bifurcation during use and leaking was noticed.The ng tube has been replaced.There was no patient harm reported.
Additional Manufacturer Narrative
Emdr evaluation codes: "leaking" code has been added.
Additional Manufacturer Narrative
Evaluation summary.A review of the device history record could not be conducted because a lot number was not provided.A sample without original package or lot number was received for evaluation.After performing a visual inspection, the reported condition was observed that the connector is detached at the bifurcation.The reported condition was confirmed.The analysis performed by the team concluded that the main root cause is that this condition is a workmanship issue.This happens when an operator fails to complete an assembly or follow 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 have better control over the assembly process.A new solvent dispenser allows a better handling of the solvent.This complaint will be used for tracking and trending purposes.

• Brand Name: ENTRFLX 10FR;43IN W/STY YPORT
• 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: 9354479
• Report Number: 9612030-2019-02361
• Device Sequence Number: 480228
• Product Code: KNT
• UDI-Device Identifier: 10884521582880
• UDI-Public: 10884521582880
• 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): 01/28/2020

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: 8884721088E
• Device Catalogue Number: 8884721088E
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/15/2019
• Supplement Date Received by Manufacturer: 11/15/2019; 11/15/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 11/21/2019; 02/07/2020
• Patient Sequence Number: 1