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

Model Number	66120
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A leak was identified on one sample of product 66120-a7926 while pooling medication at a patient's home.The customer indicated that the leak was identified by a health professional, there was no patient involvement, and no related death or serious injury caused by the event.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be filed.

• 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 2655
• Manufacturer (Section G): METRIX DOMINCANA; parque industrial itabo; building 5; san cristobal, dom ; DR
• Manufacturer Contact: demitrianna soppe ; 4400 chavenelle road; dubuque, IA 52002-4704 ; 5635568800
• MDR Report Key: 17813876
• Report Number: 1937141-2023-00021
• Device Sequence Number: 7380137
• Product Code: KPE
• UDI-Device Identifier: 00812496011657
• UDI-Public: 00812496011657
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/14/2023

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: 66120
• Device Catalogue Number: 66120
• 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: 08/28/2023
• Initial Report FDA Received Date: 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2023
• 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