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

Model Number 8884711519

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2020

Event Type  malfunction  

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 Description

The customer reported that on (b)(6) 2020, they inserted 1st silicone ngt tube and noticed milk had a very slow flow.On (b)(6) 2020, the ngt tube was removed and noticed that there was a kink at the ngt tube near to the ending part.New silicone ngt tube was inserted.There was no patient injury.

Manufacturer Narrative

The lot number was provided and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.One photograph was received for the analysis.Based on the photograph provided, it is not possible to confirm the reported condition.The customer has confirmed that the device was discarded.A physical sample is required to evaluate the reported issue.Without a physical sample being returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.A corrective action is not applicable at this time.The current process is running according to product specifications, meeting all quality acceptance criteria.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

• Brand Name: UNWTD KANG FEED TUBE 14FR
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 10165868
• MDR Text Key: 198740184
• Report Number: 9612030-2020-02502
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521009691
• UDI-Public: 10884521009691
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8884711519
• Device Catalogue Number: 8884711519
• Device Lot Number: 1916507864
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/03/2020
• Patient Sequence Number: 1
• Patient Age: 78 YR