MAUDE Adverse Event Report: CARDINAL HEALTH 777503 JOEY ENPLUS 3-IN-1 SET X30; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 777503

Device Problem Air/Gas in Device (4062)

Patient Problems Abdominal Pain (1685); Hypoglycemia (1912)

Event Date 04/21/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that the feed is set up and on run (3 in 1 feed set only).The child awakes in distress and there are numerous air gaps in the feeding tube.The ambulance was called and the child was admitted to the hospital.They experienced low blood sugar, gastro distress and was unwell.They were admitted for 2 nights in the hospital.

Manufacturer Narrative

Samples were not received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue and determine a root cause.A corrective and preventive action has been initiated to address the reported issue.If a sample is received at a later date, this complaint will be reopened for further investigation.This complaint will be used for tracking and trending purposes.

Manufacturer Narrative

A decontaminated representative sample was received at the plant for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Upon a visual and functional evaluation of the sample, the defect was not confirmed.

• Brand Name: 777503 JOEY ENPLUS 3-IN-1 SET X30
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; sragh industrial estate, co, t; offaly ; EI
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 16938985
• MDR Text Key: 315295891
• Report Number: 9611018-2023-00592
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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,Followup
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 777503
• Device Catalogue Number: 777503
• Device Lot Number: 22EO34FHX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2023
• 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): Required Intervention