MAUDE Adverse Event Report: COVIDIEN 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	07/30/2021
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 that during setup/preparation there was a solution leakage in the hole near the connector.There was patient involvement; but, no patient injury, medical intervention or adverse reaction was associated with this event.
Additional Manufacturer Narrative
A device history record review reveled no abnormal process conditions were present during the manufacturing of the product that could have led to the condition described by the customer.A physical sample was not returned; however, a video was submitted for review.After reviewing the video, a leak is observed in the bushing of the device.The reported condition is confirmed.A review of the manufacturing process was conducted.Overall, processes and controls were found to be followed, including sub-assemblies, finished product assembly, and product packaging and inspections.During the analysis of the reported condition, the probable root cause was attributed to the manufacturing equipment used in the production of this device.In order to mitigate the reoccurrence of the reported condition, the manufacturing equipment was serviced and worn parts were replaced.A check list for equipment maintenance was created to document the revised inspections and implementations.

• Brand Name: EPUMP FEED AND 1000MLFLUSH SET
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 12305185
• Report Number: 9612030-2021-03022
• Device Sequence Number: 3970517
• 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,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2021

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: Health Professional
• Device Model Number: 773662
• Device Catalogue Number: 773662
• Device Lot Number: 2100210764
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/08/2021
• Supplement Date Received by Manufacturer: 08/08/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 09/30/2021
• Patient Sequence Number: 1