MAUDE Adverse Event Report: COVIDIEN DOBBHOFF 8FR;43IN W/STYLTY SI; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884710859E
Medical Device Problem Codes	Complete Blockage (1094); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2020
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.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reports that the enfit connection is clogging and leaking after being in place for seven days.No patient injury.
Additional Manufacturer Narrative
Investigation summary: a decontaminated sample was received at the plant for the investigation.Because a lot number was not provided, the device history record could not be performed.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Upon a visual evaluation of the sample, an occlusion was confirmed, a white mass with a strong smell of medicine was found at the end of the tube; however, there were no leak conditions found in the sample.An investigation was conducted with the multifunctional team.All process and controls were found properly followed, including sub-assemblies, finished product assembly, packaging and inspections performed to the product.There were no abnormal conditions found in our process that could trigger the reported condition.Based on the available information, the most likely root cause indicates that this issue could occur due to inadequate use of the procedure if the instructions for use (ifu) are not followed.Feeding tubes should be flushed frequently to prevent clogging.Suggested flushing schedule is: a) before and after each feeding b) before and after administering medication c) once every four hours during continuous feeding or between intermittent feedings d) each time the feeding set is disconnected e) each time the feeding container is filled/changed f) each time the pump is stopped.The ifu states to use only tap or sterile water to flush.Do not use solutions containing meat tenderizer to flush or open a clogged feeding tube.Administration of medications should be guided by hospital policy.Many liquid preparations contain sorbitol which tends to interact with enteral formulas and clog the feeding tube.Thoroughly crush tablets, excluding enteric tablets which should never be crushed; however, always consult with your pharmacist regarding which tablets should be crushed for feeding tube administration.No action plan is deemed necessary at this time since the reported condition was not confirmed to be manufacturing related.The current process is running according to product specifications meeting quality acceptance criteria.We will keep monitoring the process for any adverse trends that require immediate attention.

• Brand Name: DOBBHOFF 8FR;43IN W/STYLTY SI
• 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: 10413717
• Report Number: 9612030-2020-02568
• Device Sequence Number: 14420262
• Product Code: KNT
• UDI-Device Identifier: 10884521582880
• UDI-Public: 10884521582880
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 03/04/2021

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: 8884710859E
• Device Catalogue Number: 8884710859E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 03/04/2021
• Patient Sequence Number: 1