MAUDE Adverse Event Report: COVIDIEN ENTRFLX 12FR;43IN W/STYL YPOR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884721252E
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2019
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
A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.One decontaminated sample was received at the manufacturing site for evaluation.The sample arrived without the original packaging or lot number.Upon a visual and functional evaluation of the sample, the reported issue was confirmed; the connector was leaking.A root cause analysis indicated that the reported issue has resulted from a workmanship issue.A connector leaking is a condition generated when an operator fails to complete an assembly or follow the predetermined process steps to assure a complete assembly.As part of continuous improvements, a corrective action has been opened to address the reported issue.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 a better control with the process assembly by implementing a new solvent dispenser for a better handling of the solvent.This action is designed to prevent the reoccurrence of the reported condition.

• Brand Name: ENTRFLX 12FR;43IN W/STYL YPOR
• 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: 9355418
• Report Number: 9612030-2019-02363
• Device Sequence Number: 2403501
• 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
• Report Date (Section B): 02/05/2020

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: 8884721252E
• Device Catalogue Number: 8884721252E
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/15/2019
• Supplement Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 02/05/2020
• Patient Sequence Number: 1