MAUDE Adverse Event Report: COVIDIEN POLYUR FEED TUBE 6.5FR X 20; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	461420
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2019
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 the feeding tube was put in and came apart while being used right then.The purple hub at the top where the syringe attaches actually detached from the tube that goes into the patient.The tube was just put into the patient and it was the first time that it was going to be used when the purple hub detached from the tubing.The tube was immediately taken out of the patient and replaced with a new one.There was no harm to the patient as the tube was taped well and the nurses were quick in removing it from the patient.

• Brand Name: POLYUR FEED TUBE 6.5FR X 20
• 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: 9586826
• Report Number: 9612030-2020-02391
• Device Sequence Number: 3603616
• Product Code: KNT
• UDI-Device Identifier: 10884521067936
• UDI-Public: 10884521067936
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/14/2020

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: 461420
• Device Catalogue Number: 461420
• Device Lot Number: 1924640864
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 01/14/2020
• Patient Sequence Number: 1