BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTAMIX

    MDR report key: 16572426 · Received March 20, 2023

    Report

    Report Number
    1937141-2023-00011
    Event Type
    Malfunction
    Date Received
    March 20, 2023
    Date of Event
    February 16, 2023
    Report Date
    March 20, 2023
    Manufacturer
    THE METRIX COMPANY
    Product Code
    KPE
    UDI-DI
    00085412477466
    PMA / PMN Number
    K960581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE BAG APPEARS TO HAVE MADE CONTACT WITH A SHARP OBJECT PRIOR TO FILLING. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    PHARMACY REPORTED ONE UNIT "HAD A PINHOLE LEAK IN THE LIPID PHASE SECTION OF THE BAG. ERROR WAS DETECTED AFTER COMPOUNDING , BUT BEFORE RELEASE. THE ONLY COMPONENT ADDED TO BAG BY INJECTION WITH NEEDLE WAS 0.68ML INTO THE CLEAR PHASE OF THE BAG." THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1766650 EXACTAMIX 1500 ML EMPTY EVA DUAL CHAMBER BAG KPE THE METRIX COMPANY H938901 63615-A7568 00085412477466

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown