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

Model Number	775659
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
As reported through anvisa notification (b)(4) - the nutrition diet was leaking from the equipment.

• Brand Name: EPUMP SAFETY SCREW SPIKE SET
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11979621
• Report Number: 1282497-2021-10248
• Device Sequence Number: 3592494
• Product Code: LZH
• UDI-Device Identifier: 10884521155831
• UDI-Public: 10884521155831
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/10/2021

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
• Operator of Device: No Information
• Device Model Number: 775659
• Device Catalogue Number: 775659
• Device Lot Number: 202860058
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 06/10/2021
• Patient Sequence Number: 1