MAUDE Adverse Event Report: COVIDIEN ENTFLX 12FR;43W/OSTYL W/Y PRT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884721237E

Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/25/2020

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

Customer reports: the feeding tube connector was leaking and disconnected.

Manufacturer Narrative

the initial report was submitted against an enteral feeding pump set, product 775100.Based on additional information from the manufacturing site along with a further review of the information provided by the customer, it has been determined that the device involved in this incident was an enteral feeding tube with an unknown product number.Based on this information, the following sections have been updated to reflect the new information:

section d1 brand name: updated from epump 1000ml safety screw spik to unknown enteral access
section d2 product code: updated from lzh to knt
section d2 common device name: updated from pump, infusion, enteral to tubes, gastrointestinal (and accessories)
section d4 model number: updated from 775100 to unknown enteral access
section d4 catalog number: updated from 775100 to unknown enteral access
section h6 medical device problem code: added 2907 detachment of device or device component

if additional pertinent information becomes available, the report will be updated.

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 release of product.The physical sample was not returned for evaluation; however, two pictures of the affected device were provided for review.The reported condition was confirmed through the pictures; the feeding tube connector can be seen disconnected, a condition that causes leaks; however, it was also observed through the photos that the adapter shows some marks of damage, as if it has been forced/manipulated with some instrument.A review through the manufacturing process was conducted.In general, all process and controls were found properly followed, including sub-assemblies, finished product assembly and packaging and inspections performed to the product.There were no abnormal conditions found that could trigger the reported condition.In addition, quality control inspections were found performed for material release and a 100% visual inspection was performed by the production personnel during the packaging process in order to detect and discard any identified defects.As well, in relation to the marks of damages observed in the product photos, no similar conditions have been presented/detected in our manufacturing process.Per the investigation results previously described it was concluded that the root cause could not be found related to manufacturing or production process.The most likely root cause is due to the extraction of the adapter cap being improperly forced, which could lead to a break causing the disconnection/leak.Since the failure reported by the customer was not confirmed to be generated by the manufacturing site; no action plan is deemed required.The current process is running according to product specifications meeting quality acceptance criteria.We will keep monitoring the process for any adverse trends that require immediate attention.

Manufacturer Narrative

follow up report #2 was submitted against an unknown device due to limited information at the time.Based on additional information received on 5-jan-2021 which provided the product number, the following sections have been updated:

section d1 brand name: updated from unknown enteral access to entflx 12fr;43w/ostyl w/y prt
section d4 model number: updated from unknown enteral access to 8884721237e
section d4 catalog number: updated from unknown enteral access to 8884721237e

if additional pertinent information becomes available, the report will be updated.

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• Brand Name: ENTFLX 12FR;43W/OSTYL W/Y PRT
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10461303
• MDR Text Key: 204601022
• Report Number: 1282497-2020-09386
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521155817
• UDI-Public: 10884521155817
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,user facilit
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8884721237E
• Device Catalogue Number: 8884721237E
• Date Manufacturer Received: 08/26/2020
• Patient Sequence Number: 1