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 Nausea (1970); Discomfort (2330)

Event Date 05/02/2023

Event Type  malfunction  

Event Description

Customer reports: after 5- 10 mins running 30, 40 seconds, the patient was burping, wind and complaining noticed that the air was in line.Air is being fed down the line, where the lever goes into the pump and then being pushed down line.The patient started burping and nauseous injection due to the air.The patient became unwell.At 5-10 minutes into the feed the sets were changed and same happened again and again.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.Device evaluation comment - the customer stated that the device will not be returned for evaluation because it was contaminated.The patient had a contagious infection.

Manufacturer Narrative

A device history record (dhr) review for the two potential lot #¿s 22e034fhx & 22d213fhx showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.The complaint report states that there is no sample available in relation to this report.Without a sample we are unable to perform a thorough follow up investigation to include functional and visual evaluation and to determine the root cause(s) of the reported condition.If a sample should be returned the complaint report will be reopened and updated as required.The root cause and action plan will be documented through a formal corrective/preventative action which has been initiated to address the reported condition to mitigate any further occurrences.This action is currently ongoing.This complaint will be closed with no further action and will be used for tracking and trending purposes.

• 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; manfield 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: 16966000
• MDR Text Key: 315675171
• Report Number: 9611018-2023-00595
• 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,Consumer,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 777503
• Device Catalogue Number: 777503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/19/2023
• 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