MAUDE Adverse Event Report: COVIDIEN UNWTD KANG FEED TUBE 14FR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884711519
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; 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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer stated after the kangaroo feeding tube 14 fr was inserted into the patient, the side port opened during feeding and feed was leaking from the side port.The user had to tape the side port with micropore to prevent it from opening.There was no harm to the patient.

• Brand Name: UNWTD KANG FEED TUBE 14FR
• 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: 10249930
• Report Number: 9612030-2020-02526
• Device Sequence Number: 19502940
• Product Code: KNT
• UDI-Device Identifier: 10884521009691
• UDI-Public: 10884521009691
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 07/09/2020

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: 8884711519
• Device Catalogue Number: 8884711519
• Device Lot Number: 1916507864
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 07/09/2020
• Patient Sequence Number: 1