MAUDE Adverse Event Report: COVIDIEN 10FRX36 UNWGTD FEED TBE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884711006
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2020
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 they were able to give fluid through the feeding tube via a dale ace connector when the tubing end was placed in a sink but when trying to do this on the patient's tube, they were not able to flush the tubing.The have tried several ace connectors from their stock and all worked fine leading them to believe that there is an issue with the tube.There was no patient injury.Additional information provided by the customer stated that the nurses ended up using declogging medication (creon) which worked.The patient's tube was removed on (b)(6) 2020.There had not been any meds put down the tube when the issue occurred.The patient had the tube for meds only but had not yet had any.The stylet was out of the tube when the issue occurred.
Additional Manufacturer Narrative
Please note: section d4 has been updated to display the corrected item code of 8884711006 which has been provided by the customer.As a result, the udi number was also updated to (b)(4).

• Brand Name: 10FRX36 UNWGTD FEED TBE
• 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: 10675014
• Report Number: 9612030-2020-02658
• Device Sequence Number: 13596065
• Product Code: KNT
• UDI-Device Identifier: 10884521009707
• UDI-Public: 10884521009707
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2020

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: 8884711006
• Device Catalogue Number: 8884711006
• Device Lot Number: 2011200264
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 10/14/2020
• Patient Sequence Number: 1