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

Model Number	66041
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer stated that 15 samples of product were identified leaking during the filling process at the pharmacy.Product identified leaking by the pharmacy was embossed with identification indicating the product was manufactured on cavity 6 from the manufacturing environment.Samples from the impacted lot were returned for evaluation and leaking product manufactured on cavity 6 was confirmed.The manufacturing environment was evaluated, and a tooling maintenance issue was identified.There was no report of patient involvement or injury related to this event.The investigation is ongoing.Should additional information become available, a supplemental report will be provided.
Event or Problem Description
The customer stated "it appears that the bag itself isn't sealed to the port in some cases.One other interesting thing that we have noticed - all the bags that are leaking have a small number 6 imprinted on the bag itself".15 samples were identified for leaking by the pharmacy during the compounding process.There was no patient involvement for this event.Samples from within the lot were returned for 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: 20360443
• Report Number: 1937141-2024-00010
• Device Sequence Number: 20625843
• Product Code: KPE
• UDI-Device Identifier: 50812496011553
• UDI-Public: 50812496011553
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 10/03/2024

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: 66041
• Device Catalogue Number: 66041
• Device Lot Number: A8386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2024
• 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