BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ PHLEBOTOMY SHARPS COLLECTOR, 1.5 QT NEEDLE PORT

    MDR report key: 13560801 · Received February 18, 2022

    Report

    Report Number
    2243072-2022-00247
    Event Type
    Malfunction
    Date Received
    February 18, 2022
    Date of Event
    February 8, 2022
    Report Date
    April 29, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903054879
    PMA / PMN Number
    K943139
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: PICTURES WERE RECEIVED SHOWING THE DEFECTS ON THE LIDS. THE DHR REVIEW PROCESS CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED. A REVIEW OF THE HISTORICAL NCMR¿S FOR THE AFFECTED COMPONENT (LID) UNDER PART NUMBER BDX-8990020 WAS MADE AND IT WAS FOUND THAT 6 NCS WERE GENERATED FOR THE SAME DEFECT IN THE LAST 5 YEARS, THE VERY LAST EVENT WAS REPORTED BACK IN THE LAST YEAR. THERE IS AN OBSTRUCTION BY EXCESS OF PLASTIC MATERIAL ON LID¿S SKIRT, WHICH SEEMS TO BE GENERATED BY A BROKEN INSERT IN THE MOLD. HENCE, THE LID CAN¿T FIT THE BASE WHEN TRYING TO ASSEMBLY BY END USER. ACCORDING WITH THIS EVIDENCE, WE CAN DETERMINE THIS ISSUE AS A MANUFACTURING RELATED TOPIC SINCE THIS KIND OF ISSUES ARE GENERATED DUE TO A DAMAGED ON THE MOLD (BROKEN INSERT) DURING THE INJECTION MOLDING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD¿ PHLEBOTOMY SHARPS COLLECTOR, 1.5 QT NEEDLE PORT THE LID WAS FOUND TO BE DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER'S VERBATIM REPORT IS THAT ONE OF THE CLAWS ON THE LID WAS BROKEN AND THE LID DID NOT SHUT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD¿ PHLEBOTOMY SHARPS COLLECTOR, 1.5 QT NEEDLE PORT THE LID WAS FOUND TO BE DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER'S VERBATIM REPORT IS THAT ONE OF THE CLAWS ON THE LID WAS BROKEN AND THE LID DID NOT SHUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467874 BD¿ PHLEBOTOMY SHARPS COLLECTOR, 1.5 QT NEEDLE PORT HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 305487 UNKNOWN 00382903054879

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown