MAUDE Adverse Event Report: COVIDIEN EXT SET BIFURCATED 60 ENFIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	60ENY
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/28/2020
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 when they attached the syringe to the tubing and went to flush it with the milk that it would not flush.They had to change to another tubing that did work.This was not a situation where the tubing was already infusing.They also have found that it did not matter whether they were using breastmilk or formula, they can not flush anything through the tubing.This is before they attached it to the feeding tubing.There was no patient injury.

• Brand Name: EXT SET BIFURCATED 60 ENFIT
• Common Device Name: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 10136289
• Report Number: 9612030-2020-02493
• Device Sequence Number: 3866735
• Product Code: PIF
• UDI-Device Identifier: 10884521212091
• UDI-Public: 10884521212091
• 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
• Report Date (Section B): 06/09/2020

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: 60ENY
• Device Catalogue Number: 60ENY
• Device Lot Number: 1922519964
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 06/09/2020
• Patient Sequence Number: 1