BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML S/T W/NDL 26X5/8 RB

    MDR report key: 9203616 · Received October 17, 2019

    Report

    Report Number
    1213809-2019-01054
    Event Type
    Malfunction
    Date Received
    October 17, 2019
    Date of Event
    October 1, 2019
    Report Date
    November 7, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095972
    PMA / PMN Number
    K980580
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE 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 REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE SYRINGE 1ML S/T W/NDL 26X5/8 RB HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED PATIENT CANNOT WITHDRAW MEDICATION AND WHEN INJECTING MEDICATION THE DRUG HAS COME OUT OF THE SIDE OF SYRINGE. "COMPLAINT DESCRIPTION: ON 27SEP219 DRUG SAFETY RECEIVED AN EMAIL FROM A PHARMACY . PER EMAIL THE PATIENT STATED ON OCCASIONS HE IS NOT ABLE TO WITHDRAW MEDICATION FROM VIAL. AND WHEN INJECTING THE MEDICATION, THE DRUG COMES OUT OF THE SIDE OF SYRINGE."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE SYRINGE 1ML S/T W/NDL 26X5/8 RB HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED PATIENT CANNOT WITHDRAW MEDICATION AND WHEN INJECTING MEDICATION THE DRUG HAS COME OUT OF THE SIDE OF SYRINGE. "COMPLAINT DESCRIPTION: ON (B)(6) 2019 DRUG SAFETY RECEIVED AN EMAIL FROM A PHARMACY . PER EMAIL THE PATIENT STATED ON OCCASIONS HE IS NOT ABLE TO WITHDRAW MEDICATION FROM VIAL. AND WHEN INJECTING THE MEDICATION, THE DRUG COMES OUT OF THE SIDE OF SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000003 SYRINGE 1ML S/T W/NDL 26X5/8 RB PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9070752 30382903095972

    Patients

    Seq Age Sex Outcome Treatment
    1 Other