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 Type  malfunction  

Event Description

Customer reports: there is air in the tubing coming from the free flow valve.The pump does not sound an alarm but is noisier than usual according to the patient.The tubing was changed using a different batch number and the situation did not recur with the second tubing.

Manufacturer Narrative

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

Manufacturer Narrative

The device history record (dhr) review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process 22e128fhx.The complaint report states that no sample would be returned in relation to this report.Without a sample we are unable to perform a thorough follow up investigation to include a 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 in the future, this complaint will be reopened, and the investigation updated to reflect our findings.Unfortunately, without a sample we are unable to confirm the reported condition.Since this complaint will be considered unconfirmed, no corrective or preventive actions will be taken at this time.

• 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: 15673715
• MDR Text Key: 307025167
• Report Number: 9611018-2022-00567
• 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,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2023

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: 10/25/2022
• Initial Date FDA Received: 10/26/2022
• Supplement Dates Manufacturer Received: 10/25/2022
• Supplement Dates FDA Received: 01/12/2023
• 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