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

Model Number	8884710859
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
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 incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Event or Problem Description
The customer reported that a weighted/styleted feeding tube was placed by a clinician into a patient.After x-ray confirmation, there was an attempt to remove the stylet.It was reported that the clinician had difficulty.The resulting effort to remove the stylet caused the stylet cap to break off and the stylet retracted back into the feeding tube.The entire tube was removed, including stylet, and the patient was unharmed.
Additional Manufacturer Narrative
A device history record of the reported lot number could not be conducted because a lot number was not provided.One picture was provided for evaluation however visually, the reported condition could not be confirmed.One decontaminated sample outside of the original package and without a printed lot number was received for evaluation.One device was received without a lot number and outside of its original packaging.The sample was evaluated but the reported issue was not present; the stylet was not difficult to remove and was not detached.Based on the functional evaluation, the reported condition could not be confirmed; the product meets specifications.A review through the manufacturing process was conducted.In general, all process and controls were found properly followed, including sub-assemblies, finished product assembly and packaging and inspections performed on the product.There were no abnormal conditions found that could trigger the reported condition.The potential cause may be attributed to the manner of which the device was used including any form of repositioning or movement of the product.If excessive force is used when inserting/extracting the stylet, it can damage the device.The instructions for use (ifu) states that the proper procedure for insertion of the feed tube and extraction of the stylet for stylet placement; using a syringe, inject approximately 10 cc of water into the tube to activate the hydromer coating.The current process is running according to product specifications meeting quality acceptance criteria.We will continue monitoring the process for any adverse trends that require immediate attention.

• Brand Name: DOBHFF 8FR;43IN W/STYLTY SITE
• 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: 10623273
• Report Number: 9612030-2020-02636
• Device Sequence Number: 11674951
• Product Code: KNT
• UDI-Device Identifier: 10884521518766
• UDI-Public: 10884521518766
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/23/2020

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: 8884710859
• Device Catalogue Number: 8884710859
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 11/24/2020
• Patient Sequence Number: 1