MAUDE Adverse Event Report: CARDINAL HEALTH JOEY 1000ML FEED/FLUSH SET; PUMP, INFUSION, ENTERAL

Model Number	763662
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported there was air pushing into the tube during patient use with leakage from the formula but no adverse effect from the patient.Per additional information provided on (b)(6) 2023, the formula appeared to be coming out of somewhere in the tubing attachments inside the pump, she believes it was from the valve and the formula went inside the digital display of the pump at one point.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The device was manufactured on july 11, 2023.There were no physical samples or photos received for the investigation.Because a sample was not returned, we were unable to perform functional and visual evaluations to confirm the reported condition or determine the root cause.If a sample is received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.The appropriate staff has been notified of this complaint with the purpose of raising awareness.Not further corrective action is applicable at this time.Functional testing and visual inspections are performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.

• Brand Name: JOEY 1000ML FEED/FLUSH SET
• Common Device Name: 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: 17984684
• Report Number: 9612030-2023-03841
• Device Sequence Number: 8277878
• Product Code: LZH
• UDI-Device Identifier: 10884521072312
• UDI-Public: 10884521072312
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2024

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: 763662
• Device Catalogue Number: 763662
• Device Lot Number: 2318515064
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2023
• Supplement Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown