MAUDE Adverse Event Report: THE METRIX COMPANY IMS EVA BAG 150ML 2 PORT; IMED EVAC BAG

Model Number	68045
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One eva bag 150ml was returned for evaluation & analysis of root cause.The results of the returned sample evaluation did not identify evidence of a manufacturing-related nonconformance.The particulate was identified after filling, and the customer confirmed the use of a needle during product handling.In addition the observations at the injection site and the characteristics of the recovered particulate are consistent with contact between a sharp object (e.G., a needle) and the injection site wall during product use.Based on the available evidence, the investigation supports use-related interaction with the injection site as the most likely source of the observed particulate.No evidence of a manufacturing-related nonconformance was identified during evaluation.
Event or Problem Description
On 22-apr-2026, fda informed manufacturer of three (3) medwatch reports filed by end-user describing 'glass-like particulate' inside a eva bag after filling.This was subsequent to distributor informing manufacturer of same complaint on 31-mar-2026, but with no returned product available for evaluation, a root cause analysis could not be determined.After receipt of fda letters, manufacturer reached out to end-user for additional details and another request for product return.This report serves a follow-up to medwatch report #s mw5186093, mw5186094, & mw5186095 which provides details on returned product investigation (affected product received 15-may-2026).

• Brand Name: IMS EVA BAG 150ML 2 PORT
• Common Device Name: IMED EVAC BAG
• Manufacturer (Section D): THE METRIX COMPANY; 4400 chavenelle rd; dubuque IA 52002
• Manufacturer (Section G): THE METRIX COMPANY; 4400 chavenelle rd; dubuque IA 52002
• Manufacturer Contact: patricia ayers ; 4400 chavenelle rd; dubuque, IA 52002 ; 5635568800
• MDR Report Key: 25257347
• Report Number: 1937141-2026-00002
• Device Sequence Number: 13389749
• Product Code: KPE
• UDI-Device Identifier: 00812496011305
• UDI-Public: 00812496011305
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2026

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 Expiration Date: 06/27/2026
• Device Model Number: 68045
• Device Catalogue Number: 68045-E1110
• Device Lot Number: A8441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2024
• 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