BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 1ML S/T W/NDL 27X1/2 RB

    MDR report key: 19591629 · Received June 23, 2024

    Report

    Report Number
    1213809-2024-00405
    Event Type
    Malfunction
    Date Received
    June 23, 2024
    Date of Event
    June 5, 2024
    Report Date
    August 13, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096238
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: ONE SAMPLE AND ONE PHOTO WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT WAS OBSERVED THAT THE SAMPLE HAS DOUBLE NEEDLE. THE EXTRA NEEDLE IS ATTACHED TO THE OUTER SIDE OF THE NEEDLE HUB. NO OTHER DEFECT OR IMPERFECTION WAS OBSERVED. THIS DEFECT COULD OCCUR IF THERE WAS A MISFEEDING OF THE CANNULATOR. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 3143581. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. VERIFICATION OF THE CANNULATOR WAS PERFORMED. THE SETTINGS WERE CORRECT, AND THE FLOW OF PRODUCT WAS GOOD. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED IS CONFIRMED.

    Description of Event or Problem · 0

    MATERIAL # 309623, BATCH # 3143581. IT WAS REPORTED THAT THE BD SYRINGE 1ML S/T W/NDL 27X1/2 RB NEEDLE WENT THROUGH THE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. REF (B)(4), LOT 3143581. TIP OF THE NEEDLE IS PIERCING THROUGH PART OF THE DEVICE. (B)(4) XXXXXXX XXXXXXX XXXXXXX SAMPLE YES, PT HARM: NO , 2 OCCURENCES , DOE UNKNOWN AND (B)(6) 2024.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163769 BD SYRINGE 1ML S/T W/NDL 27X1/2 RB PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3143581 30382903096238

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown