BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 19293280 · Received May 10, 2024

    Report

    Report Number
    1213809-2024-00286
    Event Type
    Malfunction
    Date Received
    May 10, 2024
    Date of Event
    April 12, 2024
    Report Date
    May 21, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO VERBATIM, THE COMPLAINT APPEARS TO BE FOR THE ABSENCE OF RETAINING RING IN THE SYRINGE BARREL. THIS PRODUCT DOES NOT HAVE A RETAINING RING BY DESIGN ACCORDING TO ITS PRODUCT SPECIFICATION. THE DESIGN OF THE PRODUCT HAS NOT CHANGED SINCE (B)(6) 2008 WHEN THE PRODUCT WAS FIRST INTRODUCED. SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED AND CORRECTIVE ACTIONS ARE NOT NECESSARY. A PHYSICAL SAMPLE IS REQUIRED FOR A MORE THOROUGH EVALUATION AND POTENTIAL ROOT CAUSE DETERMINATION.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    MATERIAL # 309628, LOT # 2321030, 2063276. IT WAS REPORTED BY CUSTOMER THAT A PLUNGER CAME LOOSE WHILE DRAWING UP THE SOLUTION NPLATE 500 MCG, RESULTING IN A SIGNIFICANT LOSS OF FLUID. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. SYRINGE STOPPER DAMAGED/DEFECTIVE ((PLUNGER CAME LOOSE) AMGEN RECEIVED NOTIFICATION ON (B)(6) 2024 FROM A PHARMACIST OF A COMPLAINT FOR NPLATE VIAL - LYOPHILIZED INVOLVING 1 UNIT FROM LOT/BATCH 1165488. THE EVENT REPORTEDLY OCCURRED ON (B)(6) 2024. THE PHARMACIST REPORTED THE FOLLOWING EVENT: A PLUNGER CAME LOOSE WHILE DRAWING UP THE SOLUTION NPLATE 500 MCG, RESULTING IN A SIGNIFICANT LOSS OF FLUID. THEREFORE, THERE IS NO LIQUID LEFT IN THE VIAL, BUT THERE IS IN THE SYRINGE. A NEW VIAL HAS BEEN PROVIDED BY THE PHARMACY.

    Description of Event or Problem · 0

    MATERIAL # 309628 LOT # 2321030, 2063276 IT WAS REPORTED THAT THE BD LUER-LOK PLUNGER ROD WAS BROKEN/DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT A PLUNGER CAME LOOSE WHILE DRAWING UP THE SOLUTION NPLATE 500 MCG, RESULTING IN A SIGNIFICANT LOSS OF FLUID. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. SYRINGE STOPPER DAMAGED/DEFECTIVE ((PLUNGER CAME LOOSE) AMGEN RECEIVED NOTIFICATION ON 12-APR-2024 FROM A PHARMACIST OF A COMPLAINT FOR NPLATE VIAL - LYOPHILIZED INVOLVING 1 UNIT FROM LOT/BATCH 1165488. THE EVENT REPORTEDLY OCCURRED ON (B)(6) 2024. THE PHARMACIST REPORTED THE FOLLOWING EVENT: A PLUNGER CAME LOOSE WHILE DRAWING UP THE SOLUTION NPLATE 500 MCG, RESULTING IN A SIGNIFICANT LOSS OF FLUID. THEREFORE, THERE IS NO LIQUID LEFT IN THE VIAL, BUT THERE IS IN THE SYRINGE. A NEW VIAL HAS BEEN PROVIDED BY THE PHARMACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2535507 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 2063276 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown