MAUDE Adverse Event Report: CARDINAL HEALTH JAPANESE CONNECT FEEDING SET 500ML; PUMP, INFUSION, ENTERAL

Model Number 77500FD-JP

Device Problem Air/Gas in Device (4062)

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

Event Date 12/30/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported air got sucked in from the cassette area.It was fine during priming, however, it occurred during feeding.The period of use is unknown.There was no patient injury.

Manufacturer Narrative

A device history record review could not be performed because a lot number was not received with the complaint.However, as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.One physical sample was received for the investigation.Visual and functional evaluations were performed and the reported condition could not be confirmed.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.

• Brand Name: JAPANESE CONNECT FEEDING SET 500ML
• 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: 18525835
• MDR Text Key: 333108753
• Report Number: 9612030-2024-00022
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

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: 77500FD-JP
• Device Catalogue Number: 77500FD-JP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2024
• Initial Date FDA Received: 01/17/2024
• Supplement Dates Manufacturer Received: 01/17/2024
• Supplement Dates FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1