MAUDE Adverse Event Report: THE METRIX COMPANY SECURE; EMPTY EVA CONTAINER WITH 2 PORTS

Model Number	66050
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No pictures or samples of the bag identified with leaking are available for metrix investigation.43 samples from lot 66050-a8460 that were not filled or identified with leaks were returned by the complaint initiator, but no leaks were identified during testing of the samples returned, and metrix is unable to confirm the defects observed by the complaint initiator.The complaint initiator confirmed 3 events of leaking product identified.For 1 event, the complaint initiator confirmed the approximate location of the leak and the cavity number embossed on the sample.No information is available confirming the total quantity of observed leaks, the leak location, or the embossed cavity number for the other events of leaking product observed.Should additional information become available, a supplemental report will be provided.
Event or Problem Description
The customer initially stated, "our compounding pharmacist let us know that the 500ml eva secure bags (ref 66050) are consistently leaking.These ones were not part of the recall from october (they have a "10" between the two ports)".Upon request for additional information, the customer further reported, "the bag was leaking fairly vigorously from the bottom of the bag, on the outside of the ports (so, not in between the ports).She thinks, but is not certain, that it was the side of the bag with the addition port.She was specific that it was a number 8 bag." this lot number (66050-a8460) was involved in the recall correction of 2 port bags manufactured from 12/8/2023 to 9/26/2024.Per recall proceedings, the finished product was sorted and repackaged to remove cavity #6 from the lot.The product leak was identified by the filling pharmacy, thus no patient contact or adverse event was reported.No samples or images of the leaking product were available to review.43 unused samples were returned from lot 66050-a8460 for metrix investigation.No additional information is available at this time.

• Brand Name: SECURE
• Common Device Name: EMPTY EVA CONTAINER WITH 2 PORTS
• Manufacturer (Section D): THE METRIX COMPANY; 4400 chavenelle road; dubuque IA 52002 4704
• Manufacturer (Section G): METRIX DOMINICANA; parque industrial itabo; building 5; san cristobal, ; DR
• Manufacturer Contact: demitrianna soppe ; 4400 chavenelle road; dubuque, IA 52002 ; 5635568800
• MDR Report Key: 21112098
• Report Number: 1937141-2024-00012
• Device Sequence Number: 12941451
• Product Code: KPE
• UDI-Device Identifier: 00812496011596
• UDI-Public: 00812496011596
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K960581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 01/08/2025

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: 66050
• Device Catalogue Number: 66050
• Device Lot Number: A8460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown