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

Model Number 8884721252

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported that the guide wire detached from the green end cap on the nasogastric tube.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.A sample has been received for the evaluation.Upon a visual evaluation of the returned sample, the reported condition is confirmed.The most likely root cause for the stylet disassembly indicates that this issue could have occurred due to the incorrect set-up of the pistons of the machine.As a preventive action, an adjustment was made to the pistons.

• Brand Name: ENTFLX 12FR;43IN W/STYL YPORT
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 9234877
• MDR Text Key: 164661363
• Report Number: 9612030-2019-02328
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521518919
• UDI-Public: 10884521518919
• 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: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8884721252
• Device Catalogue Number: 8884721252
• Device Lot Number: 1921800664
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/17/2019
• Patient Sequence Number: 1