MAUDE Adverse Event Report: THE METRIX COMPANY SECURE; 500 ML EVA CONTAINER WITH MALE SCREW CONNECTOR

Model Number	66210
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation and confirmed to contain a mobile red particle.The red particle was further analyzed by ftir method and the results suggest it could be a polymer containing vinyl acetate.A review of the manufacturing area suggests a potential source is a red adhesive used as the binding on a tear off form tablet.A production record review was conducted and there were no deviations related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a red foreign particle was identified in an empty secure 500ml eva container with male screw connector.This was discovered by a pharmacy technician prior to filling.There was no patient involvement.No additional information is available.

• Brand Name: SECURE
• Common Device Name: 500 ML EVA CONTAINER WITH MALE SCREW CONNECTOR
• Manufacturer (Section D): THE METRIX COMPANY; 4400 chavenelle road; dubuque IA 52002
• MDR Report Key: 11785688
• Report Number: 1937141-2021-00003
• Device Sequence Number: 11693585
• Product Code: KPE
• UDI-Device Identifier: 00812496011701
• UDI-Public: 00812496011701
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: user facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 05/06/2021

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 Model Number: 66210
• Device Catalogue Number: 66210
• Device Lot Number: 66210-A6956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1