MAUDE Adverse Event Report: THE METRIX COMPANY SECURE; 50ML 2 PORT EVA BAG

Model Number	66043
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that particulate was found in 3 to possibly 10 units of the secure 50 ml 2 port eva bags, lot 66043-a6929.Later it was reported an additional 3 units were identified with particulate.The particulate was noted by the same pharmacy upon inspection after the bags were filled.There is no report of patient injury or death.The particulates are in the process of being analyzed by a third party laboratory.Should additional relevant information become available, a follow-up report will be filed.
Additional Manufacturer Narrative
Should additional relevant information become available, a follow-up report will be filed.

• Brand Name: SECURE
• Common Device Name: 50ML 2 PORT EVA BAG
• Manufacturer (Section D): THE METRIX COMPANY; 4400 chavenelle road; dubuque IA 52002
• MDR Report Key: 11814890
• Report Number: 1937141-2021-00004
• Device Sequence Number: 19148943
• Product Code: KPE
• UDI-Device Identifier: 50812496011577
• UDI-Public: 50812496011577
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/27/2021

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: 10/08/2023
• Device Model Number: 66043
• Device Catalogue Number: 66043
• Device Lot Number: 66043-A6929
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 04/13/2021; 04/13/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 06/11/2021; 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1