BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19118995 · Received April 16, 2024

    Report

    Report Number
    1213809-2024-00232
    Event Type
    Malfunction
    Date Received
    April 16, 2024
    Date of Event
    March 21, 2024
    Report Date
    November 12, 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
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    MATERIAL: 309623, BATCH#: 3200782. IT WAS REPORTED THAT THE BD SYRINGE 1ML S/T W/NDL 27X1/2 RB NEEDLE WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "(B)(6)CALLED IN ABOUT ITEM 309623 LOT 3200782. CUSTOMER WAS EXPECTING THE NEEDLES TO RETRACT BUT INSTEAD THEY BROKE OFF INTO HER ARM TWICE WHILE USING THEM. ALSO STATED THAT IT IS VERY HARD FOR THE COVERS TO COME OFF TO THE POINT THAT THEY HAVE TO PRY THE COVERS OFF. PLEASE CALL BACK AT541. 912.2320." NO FURTHER INFORMATION PROVIDED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232217 BD SYRINGE 1ML S/T W/NDL 27X1/2 RB PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3200782 30382903096238

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown