MAUDE Adverse Event Report: CARDINAL HEALTH EPUMP FEED AND 1000MLFLUSH SET; PUMP, INFUSION, ENTERAL

Model Number	773662
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2021
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.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
Customer reports: during use it was evident that the bag was broken in the lower corner which caused the enteral nutrition to be completely lost.A patient was involved, but no patient injury, medical intervention, or adverse reaction was associated with this event.

• Brand Name: EPUMP FEED AND 1000MLFLUSH SET
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 12338789
• Report Number: 9612030-2021-03030
• Device Sequence Number: 14554713
• Product Code: LZH
• UDI-Device Identifier: 30884521022106
• UDI-Public: 30884521022106
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 08/18/2021

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: 773662
• Device Catalogue Number: 773662
• Device Lot Number: 2100210764
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 08/18/2021
• Patient Sequence Number: 1