MAUDE Adverse Event Report: COVIDIEN 10FR X 55 ENTRIFLEX W/STYLET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884721055
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported that the guide wire of the kangaroo ng tube could not be removed after placement, so the tube was removed.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.A sample was received for the evaluation.Upon performing visual inspection, the sample requires an insert of 10ml of water into the tube to activate the hydromer coating.After the water activate the hydromer coating, the stylet was able to remove from the tube.Therefore, the reported condition is not confirmed.The most likely root cause indicates that this issue could have occurred due to inadequate use of the procedure, if the instructions of use are not followed properly.The tube was not filled with enough water (10 cc) to remove the stylet smoothly.The feeding tubes should be flushed frequently to prevent clogging that may cause the medication and nutrition accumulation through the tube.Please refer to the instruction for use (ifu) information for 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 ifu states that a once the tube position has been confirmed, reactivate the hydromer coating with another 10 cc of water before attempting removal, if the stylet has been indwelling for any appreciable time.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for qa tracking and trending purposes.

• Brand Name: 10FR X 55 ENTRIFLEX W/STYLET
• 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: 9513600
• Report Number: 9612030-2019-02382
• Device Sequence Number: 16529531
• Product Code: KNT
• UDI-Device Identifier: 10884521518865
• UDI-Public: 10884521518865
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2020

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: 8884721055
• Device Catalogue Number: 8884721055
• Device Lot Number: 509780964X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 01/27/2020
• Patient Sequence Number: 1