MAUDE Adverse Event Report: COVIDIEN ENTRFLX 8FR;36INW/STYLTY SITE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884720825
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2021
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 that the nasogastric feeding tube guide wire would not exit the tube as it would in a functioning tube.The customer needed to remove the entire tube from the patient and restarted with new tube.It was inconvenient for the patient, but there was no harm reported.
Additional Manufacturer Narrative
One decontaminated feeding tube with packaging from the reported lot number was received for evaluation.The sample was visually analyzed.Then, the hydromer was activated.The stylet was withdrawn without problem.The reported issue was not confirmed.The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported issue.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.During the investigation, a review through the manufacturing process was conducted.All process and controls were found properly followed, including sub-assemblies, finished product assembly and packaging.There were no abnormal conditions found that could trigger the reported condition.At this time, no action plan is deemed applicable.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.Based on the dhr review and the returned sample, the model number and catalog number in section d4 was updated from 8884720825e to 8884720825.The udi # in section d4 was also updated.

• Brand Name: ENTRFLX 8FR;36INW/STYLTY SITE
• 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: 12246631
• Report Number: 9612030-2021-03011
• Device Sequence Number: 4370937
• Product Code: KNT
• UDI-Device Identifier: 10884521582941
• UDI-Public: 10884521582941
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 10/22/2021

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: 8884720825
• Device Catalogue Number: 8884720825
• Device Lot Number: 1921119064
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/26/2021
• Supplement Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 10/22/2021
• Patient Sequence Number: 1