MAUDE Adverse Event Report: CARDINAL HEALTH JOEY 1000ML PUMP SET; PUMP, INFUSION, ENTERAL

Model Number 763656

Device Problem Air/Gas in Device (4062)

Patient Problem Discomfort (2330)

Event Date 03/23/2022

Event Type  malfunction  

Event Description

Customer reports: tiny air bubbles appeared in the feeding tube section between the pump and the patient.The patient was experiencing discomfort for the last week and mother just noticed the air bubbles in the tubing today.The patient is unable to communicate verbally.

Manufacturer Narrative

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

Manufacturer Narrative

The device was not received for evaluation however photographs were provided and analyzed confirming the reported condition.  a corrective and preventive action has been initiated to address the reported issue.

• Brand Name: JOEY 1000ML PUMP SET
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 13893162
• MDR Text Key: 288047028
• Report Number: 1282497-2022-10683
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521072305
• UDI-Public: 10884521072305
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 763656
• Device Catalogue Number: 763656
• Device Lot Number: 210810122
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1