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

Model Number	66120
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a leak identified during patient infusion of a 1000 ml eva gravity bag from an apparent "slice" in the product located on the bottom of the sample.As it was identified during patient infusion, a partial loss of container contents was reported.No adverse event was reported.The customer initiated medwatch report mw5152016 for this event.The sample was not available for evaluation.No additional information was available.
Additional Manufacturer Narrative
The sample for this product complaint was not available for evaluation.The impacted sample lot number for this event was not available by the end user.Product undergoes pressure decay leak test sampling prior to final release.If a cut was made during the manufacturing process, it would have been evident during the filling process of the product and would have been visually identifiable prior to use by the patient.Given the limited information available for this event, no root cause can be determined.Should additional information 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
• Manufacturer (Section G): METRIX DOMINICANA; parque industrial itabo; building 5; san cristobal, dom ; DR
• Manufacturer Contact: demitrianna soppe ; 4400 chavenelle road; dubuque, IA 52002 ; 5635568800
• MDR Report Key: 19095678
• Report Number: 1937141-2024-00005
• Device Sequence Number: 7737100
• Product Code: KPE
• UDI-Device Identifier: 00812496011657
• UDI-Public: 00812496011657
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/09/2024

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: 66120
• Device Catalogue Number: 66120
• Device Lot Number: A8206
• 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: 03/15/2024
• Initial Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2023
• 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