MAUDE Adverse Event Report: CARDINAL HEALTH 777503 JOEY ENPLUS 3-IN-1 SET X30; PUMP, INFUSION, ENTERAL

Model Number 777503

Device Problem Air/Gas in Device (4062)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The customer reported that air was delivered into the feed line.The pump displayed a feed error and error 33 after 2ml was delivered.The event occurred at the patient's home and their mother was very distressed.

Manufacturer Narrative

Initial reporter's email address: (b)(4).An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.A sample was not received for the investigation.Without a sample we are unable to perform a thorough follow up investigation to include functional and visual evaluation to confirm the reported condition, determine the root cause(s), or implement any corrective action(s).If a sample should be returned at a later date the complaint will be reopened and the investigation updated to reflect our findings.This complaint will be used for tracking and trending purposes.

• Brand Name: 777503 JOEY ENPLUS 3-IN-1 SET X30
• Type of Device: PUMP, INFUSION, ENTERAL
• 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: 15365733
• MDR Text Key: 305162414
• Report Number: 9611018-2022-00563
• Device Sequence Number: 1
• Product Code: LZH
• 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
• Report Date: 09/26/2022

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: 777503
• Device Catalogue Number: 777503
• Device Lot Number: 21F123FHX
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/17/2022
• Initial Date FDA Received: 09/06/2022
• Supplement Dates Manufacturer Received: 08/17/2022
• Supplement Dates FDA Received: 09/27/2022
• 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