BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ NEEDLE 30X1/2 RB

    MDR report key: 9591214 · Received January 15, 2020

    Report

    Report Number
    1911916-2020-00009
    Event Type
    Malfunction
    Date Received
    January 15, 2020
    Date of Event
    December 30, 2019
    Report Date
    January 15, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051060
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 65 SAMPLES WERE RECEIVED. THEY CAME IN A SHELF BOX. THE SHELF BOX LABEL CALLS FOR THE LOT# 9193522. THE SHELF BOX HAS PRINTED THE 305105 CATALOG#. THE SAMPLES HAVE SEALED THE PACKAGING BLISTER. THEY ALL HAVE PRINTED THE LOT# 9193522 WITH THE TOP WEB HAVING PRINTED 305106, 30GX 1/2RB. THE SAMPLES WERE VISUALLY INSPECTED. THEY ALL ARE 30X ½. THE REPORTED FAILURE COULD NOT BE VERIFIED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE BD¿ NEEDLE 30X1/2 RB HAS BEEN FOUND CONTAINING MIXED PRODUCT BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE NEEDLES WERE LABELED CORRECTLY BUT CONTAINED A DIFFERENT NEEDLE. EVENT DESCRIPTION: WRONG NEEDLE INSIDE PACKAGE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ONE BD¿ NEEDLE 30X1/2 RB HAS BEEN FOUND CONTAINING MIXED PRODUCT BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE NEEDLES WERE LABELED CORRECTLY BUT CONTAINED A DIFFERENT NEEDLE. EVENT DESCRIPTION: WRONG NEEDLE INSIDE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57475 BD¿ NEEDLE 30X1/2 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305106 9193522 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other