MAUDE Adverse Event Report: CARDINAL HEALTH 777502 JOEY DUAL ENPLUS SPIKE SET X30; PUMP, INFUSION, ENTERAL

Model Number 777502

Device Problem Air/Gas in Device (4062)

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

Event Date 10/17/2022

Event Type  malfunction  

Event Description

The customer reported significant air bubbles are created from the anti-flow valve.They swapped the joey pump first, but had the same problem.They then changed batches of tubing and that solved the issue.

Manufacturer Narrative

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

Manufacturer Narrative

The device history record (dhr) review shows all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.No sample was available for evaluation.Without a sample we are unable to perform a thorough follow up investigation to include functional and visual evaluation to determine the root cause(s) of the reported condition or implement any corrective action(s).If a sample should be returned later, this complaint will be reopened and the investigation updated to reflect our findings.There was a photo provided which has been reviewed by the team.The site can confirm the presence of air in the line from the photo, but as no sample was returned, the site is unable to establish a possible root cause.At this time, a corrective and preventative action (capa) will not be initiated.Complaint trending will continue to be monitored and corrective actions will be evaluated if an increase of this failure mode occurs.This complaint will be used for tracking and trending purposes.

• Brand Name: 777502 JOEY DUAL ENPLUS SPIKE 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: 15678755
• MDR Text Key: 307024488
• Report Number: 9611018-2022-00566
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 12/12/2022

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: 777502
• Device Catalogue Number: 777502
• Device Lot Number: 22E128FHX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/18/2022
• Initial Date FDA Received: 10/27/2022
• Supplement Dates Manufacturer Received: 10/18/2022
• Supplement Dates FDA Received: 12/12/2022
• Type of Device Usage: A
• Patient Sequence Number: 1