MAUDE Adverse Event Report: CARDINAL HEALTH ENTRFLX 8FR 36INW STYLTY SITE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884720825

Device Problems Difficult to Remove (1528); Material Twisted/Bent (2981)

Patient Problem Discomfort (2330)

Event Date 05/10/2023

Event Type  malfunction  

Event Description

Customer reports: upon attempted removal of the guidewire, the tubing began to kink and the guidewire was unable to be removed.Another nasogastric tube had to be inserted.The patient was not harmed but had to have this uncomfortable procedure done twice as a result.This happened with the same patient, but it was 2 different days.The patient was confused a couple days later and removed his tube, so another needed to be inserted.The doctor had difficulty removing the stylet and after several attempts and saline flushing he was finally able to remove it.I do not know if the lot was the same for both of these tubes.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.H3: device evaluation comment - the customer stated that the device will not be returned for evaluation but did not provide rationale.

Manufacturer Narrative

Based on the information available to us, we were unable to confirm the event.In the meantime, all information received will be used for further tracking and trending purposes.If more information is received at a later date, the investigation will be reopened, and the investigation will be updated accordingly.

• Brand Name: ENTRFLX 8FR 36INW STYLTY SITE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 17065162
• MDR Text Key: 316662760
• Report Number: 9612030-2023-03716
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521009257
• UDI-Public: 10884521009257
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8884720825
• Device Catalogue Number: 8884720825
• Device Lot Number: 2016102164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1