MAUDE Adverse Event Report: THE METRIX COMPANY SECURE; 1000 ML EMPTY EVA CONTAINER WITH FEMALE SCREW CONNECTOR

Model Number	66215
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	05/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event was initially reported via mw5109973.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a contaminant was found in one unit of an empty iv bag after pooling several ivig products together.This was noted by the pharmacy after compounding.There was no patient involvement.The contaminant was described by the pharmacy as an approximately 1 cm translucent strand.

• Brand Name: SECURE
• Common Device Name: 1000 ML EMPTY EVA CONTAINER WITH FEMALE SCREW CONNECTOR
• Manufacturer (Section D): THE METRIX COMPANY; 4400 chavenelle road; dubuque IA 52002
• Manufacturer (Section G): METRIX DOMINICANA; parque industrial itabo; building 5; san cristobal, ; DR
• Manufacturer Contact: jennifer clasen ; 4400 chavenelle road; dubuque, IA 52002 ; 5635568800
• MDR Report Key: 15014054
• Report Number: 1937141-2022-00005
• Device Sequence Number: 12450909
• Product Code: KPE
• UDI-Device Identifier: 00812496011718
• UDI-Public: 00812496011718
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 07/14/2022

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: 66215
• Device Catalogue Number: 66215
• Device Lot Number: 66215-A7321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2022
• Initial Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2021
• 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