MAUDE Adverse Event Report: COVIDIEN ENTFLX 12FR;36W/OSTYL W/Y PRT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884721211E
Medical Device Problem Codes	Fluid/Blood Leak (1250); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2019
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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported the patient¿s nasogastric tube was difficult to flush, this cleared and water was able to be flushed but would come back out.
Event or Problem Description
The customer reported the patient¿s nasogastric tube was difficult to flush, this cleared and water was able to be flushed but would come back out.Additional information provided on (b)(6) 2019 stated that the nasogastric tube was leaking.
Additional Manufacturer Narrative
Event updated with additional information.Leaking was added as an additional device code.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.A sample without original packaging or lot number was received for evaluation.After performing a functional inspection the reported issue of leaking was confirmed; the device was leaking at the y connector.The reported conditions of occluded and small split in the y-port connector were not confirmed.The root cause analysis determined that 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.Changes were 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 with the process assembly by implementing a new solvent dispenser for better handling of the solvent.This complaint will be used for qa tracking and trending purposes.

• Brand Name: ENTFLX 12FR;36W/OSTYL W/Y PRT
• 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: 9342632
• Report Number: 9612030-2019-02354
• Device Sequence Number: 1927333
• Product Code: KNT
• UDI-Device Identifier: 10884521583016
• UDI-Public: 10884521583016
• 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): 02/06/2020

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: 8884721211E
• Device Catalogue Number: 8884721211E
• Device Lot Number: 1828101864
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 11/14/2019; 11/14/2019
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 12/06/2019; 02/06/2020
• Patient Sequence Number: 1