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 priming they noticed an external leak at the port.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 received for the investigation; however, a video was provided for reference.The video was visually inspected, and the reported issue was confirmed; a leak was observed in the bushing.A review of the manufacturing process was performed.Overall, all processes and controls were found to be adequately followed, including sub-assemblies, finished product assembly, and product packaging and inspections.During analysis of the production line, it was determined that the most probable root cause of this issue is related to the manufacturing process due to the mandrels being misaligned during production (between the ring and the mandrel).To prevent this issue from reoccurring, the mandrels of the large tube have been replaced and a check list was created for the documented revision of the mandrels.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: 12305210
• Report Number: 9612030-2021-03023
• Device Sequence Number: 3970519
• 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: 08/08/2021
• Supplement Date Received by Manufacturer: 08/08/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 10/04/2021
• Patient Sequence Number: 1