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

Model Number 461420

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2019

Event Type  malfunction  

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 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
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 9586826
• MDR Text Key: 175041434
• Report Number: 9612030-2020-02391
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521067936
• UDI-Public: 10884521067936
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 461420
• Device Catalogue Number: 461420
• Device Lot Number: 1924640864
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/18/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1