MAUDE Adverse Event Report: CARDINAL HEALTH GSTRO FEED TBE W/Y PRT 18FR EN; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 8884720189E

Device Problems Use of Device Problem (1670); Migration (4003)

Patient Problems Dehydration (1807); Sepsis (2067)

Event Date 09/05/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the patient passed away three days post insertion of the gastrostomy feeding tube.The balloon was inflated with 8ml of fluid.Additional information provided on (b)(6) 2022 stated that the device was inserted on (b)(6) 2021 and the patient passed away a few days later due to sepsis from dehydration.The device is believed to be a contributing cause of death as the physician had not followed the device instructions and only placed 8mls into the device, so it was only partially inflated, which caused the device to migrate and was found to not be placed into the stomach.The device was functioning and the balloon was still inflated with 8mls placed by the physician at the time of death.Prior to the placement of the gastrostomy tube, an avanos introducer kit (ref (b)(4), lot 30129240) was used.

Manufacturer Narrative

A device history record review could not be performed because a lot number was not received with the complaint.However, as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.There were no physical samples, digital images, or videos received for evaluation.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to determine the relationship between the device and cause for this event if samples are received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.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.We will continue to monitor the process, complaints, and feedback for any adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.

• Brand Name: GSTRO FEED TBE W/Y PRT 18FR EN
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• 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: 13255794
• MDR Text Key: 283808093
• Report Number: 9612030-2022-03135
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8884720189E
• Device Catalogue Number: 8884720189E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic