MAUDE Adverse Event Report: CARDINAL HEALTH EPUMP SAFETY SCREW SPIKE SET; PUMP, INFUSION, ENTERAL

Model Number	775659
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that there are air bubbles in the tube which is blocking the tube from functioning and making the machine ring.No injuries occurred.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
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 january 27, 2022.Both photos and a physical sample were received for investigation.A visual and functional inspection was performed, and the reported condition could not be duplicated in the sample received.However, a review of the photos provided did confirm the reported condition.A corrective and preventative action has been initiated to address the reported issue.

• Brand Name: EPUMP SAFETY SCREW SPIKE SET
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 15113540
• Report Number: 1282497-2022-10706
• Device Sequence Number: 5874685
• Product Code: LZH
• UDI-Device Identifier: 10884521155831
• UDI-Public: 10884521155831
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2022

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: 775659
• Device Catalogue Number: 775659
• Device Lot Number: 220240023
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2022
• Supplement Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 07/27/2022
• Supplement Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown