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

Model Number	8884720825E
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Urinary Retention (2119)
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 health care provider (hcp) reported the nasogastric tube enfit connection cracked, causing it to leak enteral feed and had to be replaced.No reported additional medical care was required apart from the tube being replaced.No reported hcp or patient injury.
Additional Manufacturer Narrative
Evaluation summary: a review of the device history record (dhr) could not be conducted because a lot number was not provided one decontaminated sample without the original package or lot number was received at the manufacturing site for evaluation.The sample was visually and functionally inspected.After this review it was observed that the enfit connector was missing from the rest of the device; this connector was not received.The reported condition was confirmed; the device does not meet specifications.The analysis performed by the team concluded that the main root cause was due to a workmanship issue generated when an operator failed to apply enough solvent to the enfit connection, causing a weak connection.A new solvent dispenser was implemented for better solvent application.This complaint will be used for tracking and trending purposes.

• 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: 10350348
• Report Number: 9612030-2020-02551
• Device Sequence Number: 3017761
• Product Code: KNT
• UDI-Device Identifier: 10884521582941
• UDI-Public: 10884521582941
• 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
• Report Date (Section B): 02/01/2021

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: 8884720825E
• Device Catalogue Number: 8884720825E
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/29/2020
• Supplement Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 07/31/2020
• Supplement Report FDA Received Date: 02/01/2021
• Patient Sequence Number: 1