MAUDE Adverse Event Report: THE METRIX COMPANY SECURE; EMPTY EVA CONTAINER WITH 2 PORTS

Model Number	66041
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that one sample of product was identified with "a port that appears to be contaminated or damaged".The customer reported the contamination appeared to be streaks down the side of the port.This was noted by the pharmacy during compounding.The sample was returned for evaluation.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
The customer reported that the injection site appeared to be damaged or contaminated.The sample was returned and evaluted, and contamination within the component was identified between the injection site sidewall and the septum of the component.Due to the location of the contamination, it was likely introduced by the component supplier.Should additional relevent information become available, a supplemental report will be submitted.

• Brand Name: SECURE
• Common Device Name: EMPTY EVA CONTAINER WITH 2 PORTS
• 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: demitrianna soppe ; 4400 chavenelle road; dubuque, IA 52002 ; 5635568800
• MDR Report Key: 19192257
• Report Number: 1937141-2024-00006
• Device Sequence Number: 7620814
• Product Code: KPE
• UDI-Device Identifier: 50812496011553
• UDI-Public: 50812496011553
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/22/2024

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: Other
• Device Expiration Date: 08/25/2024
• Device Model Number: 66041
• Device Catalogue Number: 66041
• Device Lot Number: A8160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2023
• 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