BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAVES VAG SPECULUM MEDIUM 4 X 1-3/8IN

    MDR report key: 16427501 · Received February 23, 2023

    Report

    Report Number
    1423507-2023-00086
    Event Type
    Malfunction
    Date Received
    February 23, 2023
    Date of Event
    August 5, 2022
    Report Date
    February 23, 2023
    Manufacturer
    CAREFUSION, INC
    Product Code
    HDF
    UDI-DI
    10885403042744
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    5787062 BD HAS DETERMINED THAT A PORTION OF THE PRODUCTS WERE PACKAGED AND MARKED INCORRECTLY, SPECIFICALLY: CATALOG NUMBER GL11, LOT NUMBER D22XBB MAY BE MARKED, PACKAGED, AND LABELED AS CATALOG NUMBER GL31, LOT NUMBER D22XBB - CATALOG NUMBER GL31, LOT NUMBER D22XBB MAY BE MARKED, PACKAGED, AND LABELED AS CATALOG NUMBER GL11, LOT NUMBER D22XBB. INVESTIGATION OF RETURNED COMPLAINT DEVICES LED TO AN INVESTIGATION BY THE MANUFACTURER, RESULTING IN CONFIRMATION OF A PARTIAL PRODUCT MIX FOR EACH LOT. VOLUNTARY RECALL, V. MUELLER¿ GRAVES VAGINAL SPECULUM AND PEDERSON VAGINAL SPECULA WITH BD RECALL NUMBER: BDSUR# 1423507-02/16/2023-002-C .

    Description of Event or Problem · 0

    MATERIAL# GL11 BATCH# D22XBB VERBATIM: CUSTOMER RECEIVED THE WRONG ITEM IN THE CORRECT PACKAGING. THEY RECEIVED PEDERSEN SPECULUM INSIDE A GRAVES MEDIUM (GL11). PO 24040016336. BD HAS DETERMINED THAT A PORTION OF THE PRODUCTS WERE PACKAGED AND MARKED INCORRECTLY, SPECIFICALLY: CATALOG NUMBER GL11, LOT NUMBER D22XBB MAY BE MARKED, PACKAGED, AND LABELED AS CATALOG NUMBER GL31, LOT NUMBER D22XBB - CATALOG NUMBER GL31, LOT NUMBER D22XBB MAY BE MARKED, PACKAGED, AND LABELED AS CATALOG NUMBER GL11, LOT NUMBER D22XBB. INVESTIGATION OF RETURNED COMPLAINT DEVICES LED TO AN INVESTIGATION BY THE MANUFACTURER, RESULTING IN CONFIRMATION OF A PARTIAL PRODUCT MIX FOR EACH LOT. VOLUNTARY RECALL, V. MUELLER¿ GRAVES VAGINAL SPECULUM AND PEDERSON VAGINAL SPECULA WITH BD RECALL NUMBER: BDSUR# 1423507-02/16/2023-002-C

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444262 GRAVES VAG SPECULUM MEDIUM 4 X 1-3/8IN SPECULUM, VAGINAL, METAL HDF CAREFUSION, INC GL11 D22XBB 10885403042744

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other