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 Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation as it was not saved; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported the feeding tube was in place for less than 24 hours when it came apart.The purple hub at the top where the syringe attaches actually detached from the tube that goes into the patient.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: 9586732
• MDR Text Key: 175041685
• Report Number: 9612030-2020-02389
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1