MAUDE Adverse Event Report: THE METRIX COMPANY CORMIX; 250 ML EMPTY EVA CONTAINER WITH 2 PORTS

Model Number	64045
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected unit was returned drained and the isolated particulate was received in a separate bag.The particulate had a round, flat shape and contained both clear and black areas.The particulate was sent to an external lab for analysis and the results indicate it is composed of polycarbonate.The investigation into this event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that while compounding milrinone and d5w into a cormix empty eva container with 2 ports, that an object with the appearance of legs and a wing were visible inside the bag.It was further reported that the compounding technician cut the bag and extracted it from inside using a needle to confirm that it was not coring.There was no patient involvement.No additional information is available.

• Brand Name: CORMIX
• Common Device Name: 250 ML EMPTY EVA CONTAINER WITH 2 PORTS
• Manufacturer (Section D): THE METRIX COMPANY; 4400 chavenelle road; dubuque IA 52002
• MDR Report Key: 12027225
• Report Number: 1937141-2021-00013
• Device Sequence Number: 20037847
• Product Code: KPE
• UDI-Device Identifier: 00812496011121
• UDI-Public: 00812496011121
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2021

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: 04/11/2023
• Device Model Number: 64045
• Device Catalogue Number: MS64045
• Device Lot Number: 64045-A6330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1