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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/09/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported the feeding bag blew up with air.

• 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; 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: 19079872
• MDR Text Key: 340003409
• Report Number: 9612030-2024-00057
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521072305
• UDI-Public: 10884521072305
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2024

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: 763656
• Device Catalogue Number: 763656
• Device Lot Number: 2323300764
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/09/2024
• Initial Date FDA Received: 04/10/2024
• Type of Device Usage: A
• Patient Sequence Number: 1