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	07/04/2021
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 a (b)(6) year-old male patient with cardiac arrest, who required the installation of enteral nutrition had fluid leakage in the lower part of the bag where the hole is locate.The issue occurred prior to use, a patient was not involved.
Additional Manufacturer Narrative
The device history record was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the issue reported.The device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.The device was manufactured on january 05, 2021.A physical sample was not returned for evaluation; however, a video was provided for reference.The video was inspected, and the reported issue was confirmed; a leak was observed on the perimeter side of the bag.Based on historical data for the same failure mode it was possible to identify a potential root cause which is that the perimeter area of the feeding bag could suffer over sealing (double sealing) since the perimeter die of the sealing did not contain any equipment to prevent adherence from sealed bag to the sealing die.Therefore, a leakage in the perimeter area could occur if the sealing area is damaged (over sealed) by the machine die.A historical review shows that there have been a series of improvement actions taken after the manufacturing of this lot to mitigate the risk of leakage in the perimeter area.These actions included an awareness notification being issued to production personnel, updating work instructions to clarify the disposition that the product must follow if over-sealing or weak sealing is detected, the installation of sponges on the perimeter sealing die of rf machine to avoid over-sealing in the perimeter area, the creation of a sample board for personnel/qc inspectors to clarify the acceptance/rejection criteria for weak seals, bubbles, and over seal defects, and updating the standard work instructions to include a visual aid of seal inspection to ensure that perimeter area sealing is uniform, continuous, and without openings.Production personnel was trained to the sample board implementation and standard work instruction updates.No further corrective actions are applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.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; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 12305189
• Report Number: 9612030-2021-03024
• Device Sequence Number: 3970518
• 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): 10/04/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/05/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 10/04/2021
• Patient Sequence Number: 1
• Patient Age: 50 YR