BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARPS COLL 9GAL GASKET RED

    MDR report key: 8703658 · Received June 17, 2019

    Report

    Report Number
    2243072-2019-01192
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Date of Event
    May 8, 2019
    Report Date
    July 10, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    50382903056014
    PMA / PMN Number
    K943575
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A SAMPLE AND PHOTO REPRESENTATION WERE RECEIVED FOR THE INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) AND NON-CONFORMING MATERIAL REPORT (NCMR) FOR THE REPORTED LOT WAS PERFORMED FOR THE PAST 12 MONTHS. THERE WERE NO MANUFACTURING OR MATERIAL DEFECTS REPORTED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT, ¿MISSING LIDS¿. THE SAMPLE PROVIDED MAY CONFIRM REPACKAGING BY A DISTRIBUTOR. A WEIGHING SYSTEM HAS ALREADY BEEN IMPLEMENTED AS CORRECTIVE ACTION FOR THIS CONTAINER MANUFACTURING PROCESS TO ENSURE THE CORRECT QUANTITY OF PIECES PER BOX BEFORE SHIPPING. THE WEIGHTED LABEL PLACED ON THE ORIGINAL BOX BY THE WEIGHING SYSTEM CONFIRMED THE ISSUE DID NOT OCCUR DURING MANUFACTURING. THE ROOT CAUSE IS INCONCLUSIVE. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    MATERIAL NO. 305601. BATCH NO. 9033926. IT WAS REPORTED THAT BEFORE USE OF THE SHARPS COLL 9GAL GASKET RED SHARPS CONTAINERS WERE MISSING LIDS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED A DEFECTIVE SHARPS CONTAINERS ON 5/9 AND WAS ADVISED THAT A REPLACEMENT WOULD BE SHIPPED TO OUR CUSTOMER. THE LOT NUMBER IS 9033926 AND THE CUSTOMER WAS MISSING THE LIDS.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO. 305601, BATCH NO. 9033926. IT WAS REPORTED THAT BEFORE USE OF THE SHARPS COLL 9GAL GASKET RED SHARPS CONTAINERS WERE MISSING LIDS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED A DEFECTIVE SHARPS CONTAINERS ON 5/9 AND WAS ADVISED THAT A REPLACEMENT WOULD BE SHIPPED TO OUR CUSTOMER. THE LOT NUMBER IS 9033926 AND THE CUSTOMER WAS MISSING THE LIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496923 SHARPS COLL 9GAL GASKET RED HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 9033926 50382903056014

    Patients

    Seq Age Sex Outcome Treatment
    1 Other