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	07/10/2021
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 the feeding set presented a leak through the irrigation water bag during priming.There was no patient involvement.
Additional Manufacturer Narrative
Investigation conclusion: the customer reported that the feeding set presented a leak through the irrigation water bag during priming.There was no patient involvement.This report refers to product code 773662, epump feed and 1000mlflush set, with lot number 2103421864.The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the defect described by the customer.All acceptance criteria inspections per established sampling levels were within acceptable limits during the production process for the reported lot manufactured on 16feb2021.A trend analysis performed for the reported lot number and failure made did not identify any related adverse trends.The reported device was not returned for evaluation; however, two (2) photographs were provided by the customer.Visual inspection of the photographs confirmed the report of leak.A potential root cause for the confirmed product failure was identified as a misalignment between the ring and the mandrel.Maintenance on the machinery was performed to replace the mandrels and a manufacturing checklist was implemented to prevent this confirmed product failure from recurring.At this time, additional action is not necessary.This complaint will be used for tracking and trending purposes.

• Brand Name: EPUMP FEED AND 1000MLFLUSH SET
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12188743
• Report Number: 1282497-2021-10496
• Device Sequence Number: 1480333
• 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): 10/06/2021

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: 2103421864
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/16/2021
• Supplement Date Received by Manufacturer: 07/16/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 10/06/2021
• Patient Sequence Number: 1