BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE

    MDR report key: 16521193 · Received March 10, 2023

    Report

    Report Number
    16521193
    Event Type
    Malfunction
    Date Received
    March 10, 2023
    Date of Event
    February 3, 2023
    Report Date
    February 3, 2023
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS DISCOVERED IN THE CATH LAB THAT PARTICULATES FROM A MEDICATION CORE LEAKED INTO THE MEDICATION OF A MULTI-DOSE VIAL. DEVICE WAS AN 18GX1.5 NEEDLE. THIS HAPPENED 4 TIMES WITH TWO CATALOG NUMBERS ACROSS 4 DIFFERENT LOTS, SYR100187 (LOTS 220315 AND 210505) AND 18GX SYR100185 (LOTS 220820 AND 220217) WERE ALL DETERMINED AS DEFECTED IN THE CATH LAB. THIS WAS REPEATED ACROSS MULTIPLE MEDICATION MANUFACTURES WITH THE SAME RESULT IN THE CATH LAB. MANUFACTURER RESPONSE FOR 18 GAUGE NEEDLE, MEDLINE (PER SITE REPORTER). NO RESPONSE OF SIMILAR ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1148844 MEDLINE SYRINGE, PISTON FMF MEDLINE INDUSTRIES, INC. SYR100187 210505

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown