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

Model Number 8884720858E

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)

Patient Problems Pain (1994); Discomfort (2330)

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported that there was a problem during the installation of the probe, the guide does not come out, impossible to remove, if they pull too hard, the guide tip breaks, the guide stays in the probe.Before installation of the probe, they had checked if the guide was moving by removing a few centimeters and then reinstalling it as originally fitted.Then care was taken according to good practice protocol with lubrication of the probe with the silicon spray lubricating aerosol can (lot 9005.004 ref 556000-000000 ex 6720000).After the installation of the probe, the guide remains stuck, pulling gently, or hard, or turning the guide and pulling at the same time, the guide does not move any more.When pulling the guide, the silicone probe makes little ¿folds¿.Per customer, the device was replaced.There was no problem during the nutrition.The patient had pain, discomfort, embarrassment because the doctor needed to replace another product.As the result of device malfunction, it was informed to the team to stop using the device with a guide.There was no injury to the patient involved and there was no time delay.

Manufacturer Narrative

Section b5 has been updated to include additional information.The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The product was manufactured on 08-jan-2018.A sample was not received for the investigation.Per customer, the sample was discarded.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.At this time, a corrective and preventive action is not deemed necessary.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

Event Description

The customer reported that there was a problem during the installation of the probe, the guide does not come out, impossible to remove, if they pull too hard, the guide tip breaks, the guide stays in the probe.Before installation of the probe, they had checked if the guide was moving by removing a few centimeters and then reinstalling it as originally fitted.Then care was taken according to good practice protocol with lubrication of the probe with the silicon spray lubricating aerosol can (lot 9005.004 ref 556000-000000 ex 6720000).After the installation of the probe, the guide remains stuck, pulling gently, or hard, or turning the guide and pulling at the same time, the guide does not move any more.When pulling the guide, the silicone probe makes little ¿folds¿.Per customer, the device was replaced.There was no problem during the nutrition.The patient had pain, discomfort, embarrassment because the doctor needed to replace another product.As the result of device malfunction, it was informed to the team to stop using the device with a guide.There was no injury to the patient involved and there was no time delay.Additional information was received from the sales representative and stated that she thinks that the problem is with the usage of the device and the client was reminded of the usage protocol (ifu).

• Brand Name: ENTRFLX 8FR 43INW STYLTY SITE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• 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: 14041870
• MDR Text Key: 288782892
• Report Number: 9612030-2022-03211
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521582972
• UDI-Public: 10884521582972
• Combination Product (y/n): N
• Reporter Country Code: RE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/07/2022

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: 8884720858E
• Device Catalogue Number: 8884720858E
• Device Lot Number: 1800488964
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/29/2022
• Initial Date FDA Received: 04/07/2022
• Supplement Dates Manufacturer Received: 03/29/2022
• Supplement Dates FDA Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1