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

Model Number	8884711519
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2020
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 reported that on (b)(6) 2020, a new silicone ngt tube was inserted.On (b)(6) 2020, they had noted that milk was flowing very slow and there was difficulty to give ngt feeding.On (b)(6) 2020, the silicone ngt tube was removed and they noticed a kink at about 15 cm near the end of tube.There was no patient injury.
Additional Manufacturer Narrative
One picture was provided for evaluation however based on the digital image it is not possible to confirm the reported issue.Since the physical sample has not been received for evaluation the reported issue could not be confirmed.The device history record file was reviewed and no discrepancies were found according to the issue reported.The root cause for the reported condition cannot be specifically identified; therefore, corrective action will be limited to the manufacturing awareness at this time.The current process is running according to product specifications meeting quality acceptance criteria.If the physical sample or additional information is received at a later date, the investigation will be reopened and updated as needed.We will keep monitoring the process for any adverse trends that require immediate attention.

• 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: 10165837
• Report Number: 9612030-2020-02501
• Device Sequence Number: 3083602
• 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,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2020

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
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 09/02/2020
• Patient Sequence Number: 1
• Patient Age: 78 YR