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

Model Number	8884720858
Medical Device Problem Code	Difficult to Remove (1528)
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 the guide wire adhered to the nasogastric tube and could not be removed after placing.No patient injury.
Additional Manufacturer Narrative
Additional information h2, h3, h4, h6 investigation conclusion the customer reported that the guide wire adhered to the nasogastric tube and could not be removed after placing.No patient injury.This is report is associated with product 8884720858, entrflx 8fr;43inw/stylty site, with lot number 1928803264.The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the defect described by the customer.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.Five (5) photographs were provided for evaluation.Examination of the photographs identified the tip of the stylet to appear stretched.One (1) sample was received for evaluation.Visual inspection and functional testing performed did not confirm the reported device failure.The hydromer was activated and the stylet was removed without issue, however, the tip of the stylet was dammaged.This damage may be caused if the stylet is manipulated when placed on the patient.There is a potential for the tip to get stuck in the catheter tip holes and if attempting removal, the tip would be forced to stretch.The ifu should be referenced for proper use of the product.For stylet placement; using a syringe, inject approximately 10 cc of water into the tube to activate the hydromer coating.Additional action will not be taken at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: ENTRFLX 8FR;43INW/STYLTY SITE
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 10681081
• Report Number: 9612030-2020-02659
• Device Sequence Number: 571660
• Product Code: KNT
• UDI-Device Identifier: 10884521518858
• UDI-Public: 10884521518858
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2021

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
• Device Model Number: 8884720858
• Device Catalogue Number: 8884720858
• Device Lot Number: 1928803264
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown