BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 1 ML

    MDR report key: 19133702 · Received April 18, 2024

    Report

    Report Number
    2243072-2024-00557
    Event Type
    Malfunction
    Date Received
    April 18, 2024
    Date of Event
    March 26, 2024
    Report Date
    June 27, 2024
    Manufacturer
    BD MEDICAL, MEDICATION DELIVERY SOLUTIONS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    MATERIAL# UNKNOWN LOT# UNKNOWN IT WAS REPORTED THAT THE BD SYRINGE 1 ML PLUNGER ROD WAS BROKEN/DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PLUNGER IN THE SYRINGE CAME FREE, CAUSING THE DRAWN UP MEDICATION TO SPILL ONTO THE FLOOR AND COUNTER. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED THE PLUNGER IN THE SYRINGE CAME FREE, CAUSING THE DRAWN UP MEDICATION TO SPILL ONTO THE FLOOR AND COUNTER LOT NUMBER -2082199 ITEM NUMBER -3027085 PRODUCT DESCRIPTION - SYRINGE 1ML LL.

    Description of Event or Problem · 0

    MATERIAL #: 309628. LOT #: 3027085. IT WAS REPORTED BY CUSTOMER THAT THE PLUNGER IN THE SYRINGE CAME FREE, CAUSING THE DRAWN-UP MEDICATION TO SPILL ONTO THE FLOOR AND COUNTER. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. THE PLUNGER IN THE SYRINGE CAME FREE, CAUSING THE DRAWN UP MEDICATION TO SPILL ONTO THE FLOOR AND COUNTER. LOT NUMBER: 2082199. ITEM NUMBER: 3027085. PRODUCT DESCRIPTION: SYRINGE 1ML LL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2424596 BD SYRINGE 1 ML PISTON SYRINGE FMF BD MEDICAL, MEDICATION DELIVERY SOLUTIONS 3027085 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown