BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SHARPS COLLECTOR 5.4QT RED

    MDR report key: 13261757 · Received January 14, 2022

    Report

    Report Number
    2243072-2021-03129
    Event Type
    Malfunction
    Date Received
    January 14, 2022
    Date of Event
    December 22, 2021
    Report Date
    April 21, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903055173
    PMA / PMN Number
    K943141
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OEM MANUFACTURE: 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. DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PHOTOS OR SAMPLES WERE RECEIVED IN ORDER TO IDENTIFY THE ROOT CAUSE FOR THE ISSUE. ADDITIONAL ATTEMPT TO GET MORE INFORMATION WERE MADE, HOWEVER, THE CUSTOMER CONFIRMED THAT NO ADDITIONAL INFORMATION WAS AVAILABLE. ACCORDING TO THE DHR REVIEW PROCESS, THE RESULT SHOWED THERE WERE NO ISSUES REPORTED LIKE LID BROKEN ¿ DAMAGED OR BASE BROKEN ¿ DAMAGED DURING THE MANUFACTURING PROCESS OF THE LOT NUMBER REPORTED (1052914) UNDER THIS CUSTOMER COMPLAINT. ALSO, A REVIEW OF THE NCMR¿S WAS PERFORMED; THE RESULT SHOWED THERE WERE NO ISSUES REPORTED LIKE LIDS BROKEN-DAMAGED OR BASE BROKEN-DAMAGED FOR THE SAME PART NUMBER THROUGHOUT THE LAST TWELVE MONTHS. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SHARPS COLLECTOR 5.4QT RED EXPERIENCED A CASE OF LID DAMAGE, AND A CASE OF DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE HCP NOTICED THAT THE ONE SIDE OF THE ROTATION AXIS OF THE LID AND THE BOTTOM SURFACE OF THE BASE WERE DAMAGED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SHARPS COLLECTOR 5.4QT RED EXPERIENCED A CASE OF LID DAMAGE, AND A CASE OF DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE HCP NOTICED THAT THE ONE SIDE OF THE ROTATION AXIS OF THE LID AND THE BOTTOM SURFACE OF THE BASE WERE DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626446 BD SHARPS COLLECTOR 5.4QT RED HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 305517 1052914 00382903055173

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown