MAUDE Adverse Event Report: COVIDIEN GSTRO FEED TBE W/Y PRT 12FR EN; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 8884715122E

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/31/2021

Event Type  malfunction  

Manufacturer Narrative

A 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 in the endoscopy department, the hospital recently switched to a new system for peg probes.They now use the kangaroo gastrostomy feeding tubes with enfit y-ports.The endoscopic department stated that the patient returned with a defective connection.The nurse had to take a new product and take the connector from the new product to switch it with the damaged connector.A representative photo was provided and showed that the y-port cracked in the center.There was no patient injury.Additional information provided on (b)(6) 2021 stated that the device did leak because of the y-port being torn.After attaching the feeding tube on the enfit port, they were not able to unscrew the feeding tube from the enfit port, therefor the y-port tore and leaked.

Manufacturer Narrative

The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The product was manufactured on 22-aug-2020.One picture was provided for the analysis and a representative decontaminated sample without the original packaging or a lot number has been received for the evaluation.Upon visual evaluation, damage in the enfit connector can be observed.A gemba walk was performed in the manufacturing area with the multifunctional team (quality, manufacturing, engineering) and it was determined that this reported issue could not occur at the manufacturing floor.There is currently no part of the manufacturing process that could cause a damage in the enfit connector; additionally, the sample shows signs of use which confirms that the sample arrived properly assembled to the end user.The most likely root cause is misuse of the product resulting in a broken enfit connector.Therefore, the reported issue was not generated during the manufacturing process.The production personnel were notified about the reported issue.At this time, a corrective and preventive action is not deemed necessary.

• Brand Name: GSTRO FEED TBE W/Y PRT 12FR EN
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 11982216
• MDR Text Key: 255759452
• Report Number: 9612030-2021-02932
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 10884521661622
• UDI-Public: 10884521661622
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8884715122E
• Device Catalogue Number: 8884715122E
• Device Lot Number: 2022204864
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/31/2021
• Patient Sequence Number: 1