BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE

    MDR report key: 11848208 · Received May 19, 2021

    Report

    Report Number
    1937141-2021-00006
    Event Type
    Malfunction
    Date Received
    May 19, 2021
    Report Date
    June 8, 2021
    Manufacturer
    THE METRIX COMPANY
    Product Code
    KPE
    UDI-DI
    20812496011859
    PMA / PMN Number
    K843523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INJECTION SITE IS THE ONLY PORT AVAILABLE FOR FILLING THE BAGS WITH FLUID. EACH OF THE 13 UNITS RETURNED FOR EVALUATION HAD BEEN FILLED BY THE PHARMACY. THE UNITS WERE SENT TO AN EXTERNAL LABORATORY FOR EVALUTION. THE INJECTION SITE WAS VISUALLY EXAMINED AND ALL 13 UNITS WERE CONFIRMED TO HAVE SCRAPE MARKS PRESENT ON THE INJECTION SITE WALL. AS THE PARTICULATE WITHIN EACH OF THE BAGS WAS VISUALLY SIMILAR, THREE BAGS WERE RANDOMLY SELECTED, THE PARTICULATE FROM EACH BAG WAS ISOLATED AND COMPOSITION TESTING WAS CONDUCTED. ON ALL 3 BAGS THE PARTICULATE WAS IDENTIFIED AS HAVING THE SAME COMPOSITION AS THE INJECTION SITE WALL. THE SOURCE OF THE PARTICULATE IS ASSESSED TO BE NEEDLE CONTACT WITH THE INJECTION SITE WALL DURING THE FILLING PROCESS AT THE PHARMACY. H6: INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS WERE CORRECTED BASED ON THE DEVICE EVALUATION RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PARTICULATE WAS FOUND IN 13 UNITS OF THE SECURE 100 ML 2 PORT PVC BAGS, LOT 58719-31578. THE PARTICULATE WAS NOTED BY THE 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. INITIAL VISUAL RESULTS INDICATE SCRAPE MARKS ON THE INTERIOR OF THE INJECTION SITE WHICH MAY BE CONSISTENT WITH NEEDLE CONTACT WITH THE INJECTION SITE WALL DURING THE FILLING OF THE BAG. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749526 SECURE 100 ML 2 PORT PVC BAG KPE THE METRIX COMPANY 58719 58719-31578 20812496011859

    Patients

    Seq Age Sex Outcome Treatment
    1