MAUDE Adverse Event Report: COVIDIEN EPUMP INTL 1000ML FD AND FLUSH; PUMP, INFUSION, ENTERAL

Model Number	673662
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2021
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 the feeding set leaked between the bag and the line.The issue occurred during use.There was patient involvement; but no patient injury, medical intervention or adverse reaction associated with this event.
Additional Manufacturer Narrative
Additional information: h6 evaluation codes - type of investigation; investigation findings; investigation conclusions.Investigation summary: the device history record review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.A sample was not returned to the manufacturing site for evaluation.However, two videos were provided for review.According to evidence found on the provided videos, a damaged bag was received by the customer.Based on the available information, the root cause was found to be related to the rf sealing machine process.A corrective action to replace the rf sealing machine was initiated and addressed.This complaint will be closed with no further actions at this time and will be used for tracking and trending purposes.

• Brand Name: EPUMP INTL 1000ML FD AND FLUSH
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11974894
• Report Number: 1282497-2021-10244
• Device Sequence Number: 1085754
• Product Code: LZH
• UDI-Device Identifier: 10884521028197
• UDI-Public: 10884521028197
• 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,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2021

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: 673662
• Device Catalogue Number: 673662
• Device Lot Number: 203070030
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 08/26/2021
• Patient Sequence Number: 1