MAUDE Adverse Event Report: THE METRIX COMPANY SECURE; EMPTY EVA CONTAINER WITH DETACHABLE 3 LEG TRANSFER SET

Model Number	68120
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A medwatch report was filed by a pharmacist regarding a health professional noticing a "hole in pooling bag." there is no confirmed patient involvement.Given the reporter is a pharmacist and the report's event description says "pooling bag," it is likely the event was discovered during the pooling process.It was also reported that the event regarded a two-leg bag, but the product code indicates the device was a three-leg bag.Multiple attempts to contact the reporter have been made to obtain additional details about the event, including patient involvement, the leak location, and any relevant conditions.However, the complaint reporter was unresponsive to all attempts made.Without further information regarding the details of the event, device handling, a sample to review, or the leak location, there is no further information to review, and a root cause cannot be determined.Should additional information become available, a supplemental report will be provided.
Event or Problem Description
A medwatch report mw5163137 was received on 12/19/2024 reporting a leak on one sample of product 68120-a8252 caused by a hole in the pooling bag in an undisclosed location.The report indicated limited patient information but did not confirm if the failure was identified during administration to the patient.Product and lot information were provided in the report.Photos, samples, leak location, and description of the hole were not available.No other information is available.

• Brand Name: SECURE
• Common Device Name: EMPTY EVA CONTAINER WITH DETACHABLE 3 LEG TRANSFER SET
• Manufacturer (Section D): THE METRIX COMPANY; 4400 chavenelle road; dubuque IA 52002
• 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: 21178576
• Report Number: 1937141-2024-00013
• Device Sequence Number: 12942185
• Product Code: KPE
• UDI-Device Identifier: 00812496011367
• UDI-Public: 00812496011367
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K030888
• 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): 01/13/2025

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: 68120
• Device Catalogue Number: 68120
• Device Lot Number: A7926
• 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: 12/19/2024
• Initial Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2023
• 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