MAUDE Adverse Event Report: COVIDIEN ENTFLX 12FR;36W/OSTYL W/Y PRT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884721211E
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2019
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.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer states the patient was admitted with a dobhoff tube in place, being used for tube feeds at home.The tube had been placed 12 days prior.Upon admission, the patient reported that the dobhoff had been clogged.The nurses attempted to unclog the dobhoff and upon trying to aspirate the tube, pulled back a formed white piece that looked like a piece of white rope, or piece of the inside lining of the tube itself.After aspirating, the tube remained clogged, and no further attempt was made to instill or aspirate through the line.The tube was removed and replaced.
Additional Manufacturer Narrative
A review of the device history record could not be conducted because a lot number was not provided.A photograph was submitted for evaluation.A visual inspection of the photo shows a syringe that appeared to contain a white residue.The most likely root cause indicates that this issue could occur due inadequate use of the procedure if the instructions of use are not followed.Feeding tubes should be flushed frequently to prevent clogging.If the sample is returned to be evaluate the complaint it is going to re-open to determine was is the residue.No corrective actions are deemed necessary at this moment.The process is running according to product specifications meeting quality acceptance criteria will be keep monitoring the process for any adverse trends that require immediate attention.

• Brand Name: ENTFLX 12FR;36W/OSTYL W/Y PRT
• 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: 8793496
• Report Number: 9612030-2019-02218
• Device Sequence Number: 1707874
• Product Code: KNT
• UDI-Device Identifier: 10884521583016
• UDI-Public: 10884521583016
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2019

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: 8884721211E
• Device Catalogue Number: 8884721211E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/28/2019
• Supplement Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 12/30/2019
• Patient Sequence Number: 1