MAUDE Adverse Event Report: THE METRIX COMPANY MCKESSON; EVA 2-PORT W/O LEGS 150ML

Model Number	64040
Medical Device Problem Codes	Leak/Splash (1354); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Five reports of product leaks were identified by a single downstream customer, all detected after pharmacy filling but prior to patient administration.No patient exposure, injury, or impact was reported.Failure modes included one event described as a "hole in the bag," another as "leaking at the seam," with the remaining events reported without defined leak locations.A comprehensive review of device history records, maintenance logs, and qc checks identified no nonconformances, deviations, or abnormalities.Because the affected samples were discarded by the end user and not returned for evaluation, the reported failures could not be independently confirmed through investigation.No evidence of a systemic manufacturing defect has been identified.No additional information is available at this time; should further information become available, a supplemental report will be provided.
Event or Problem Description
The customer reported five events of leaking eva 150 ml bags from a single lot.Leaks were identified by caregivers after pharmacy filling but prior to patient administration.One report described a hole in the bag, another described leakage along the seam, and the remaining leak locations were not disclosed.All product samples were discarded by the end users and were not available for evaluation.As the leaks were detected before administration, there was no patient involvement or harm.No further information has been provided.

• Brand Name: MCKESSON
• Common Device Name: EVA 2-PORT W/O LEGS 150ML
• Manufacturer (Section D): THE METRIX COMPANY; 4400 chavenelle road; dubuque IA 52001
• 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: 23020536
• Report Number: 1937141-2025-00005
• Device Sequence Number: 18535040
• Product Code: KPE
• UDI-Device Identifier: 10612479272122
• UDI-Public: 10612479272122
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2025

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: 64040
• Device Lot Number: A8648
• 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: 08/11/2025
• Initial Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2025
• 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