BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUASHIELD 3 ML SYRINGE

    MDR report key: 11421795 · Received March 4, 2021

    Report

    Report Number
    MW5099802
    Event Type
    Malfunction
    Date Received
    March 4, 2021
    Date of Event
    March 2, 2021
    Report Date
    March 2, 2021
    Manufacturer
    EQUASHIELD LLC
    Product Code
    ONB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    EQUASHIELD 3 ML SYRINGES HAVE LIQUID LEAKING PAST THE BLACK RUBBER PLUNGER. WE TRIED 3 DIFFERENT SYRINGES FROM THIS LOT NUMBER AND THEY ALL LEAKED PAST THE PLUNGER; LOT: 200068. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311820 EQUASHIELD 3 ML SYRINGE CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB EQUASHIELD LLC 200068
    311821 EQUASHIELD 3 ML SYRINGE CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB EQUASHIELD LLC. 200068
    311822 EQUASHIELD 3 ML SYRINGE CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB EQUASHIELD LLC. 200068

    Patients

    Seq Age Sex Outcome Treatment
    1