BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9262639 · Received October 31, 2019

    Report

    Report Number
    1213809-2019-01088
    Event Type
    Malfunction
    Date Received
    October 31, 2019
    Date of Event
    October 16, 2019
    Report Date
    November 13, 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, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. FURTHERMORE, 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    MATERIAL NO. 309597, BATCH NO. 9070752. IT WAS REPORTED THAT DURING USE OF THE SYRINGE 1ML S/T W/NDL 26X5/8 RB THE NEEDLES WERE DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENT STATES A LOT OF THE NEEDLES USED TO INJECT THE MEDICATION WERE DEFECTIVE AND NOW SHE IS SHORT ABOUT A WEEKS WORTH. IT IS UNKNOWN IF THE PATIENT STILL HAS THE PENS ON HAND. IT IS ALSO UNKNOWN IF A DOSE WAS MISSED. EXPIRATION DATE IS UNKNOWN."

    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

    MATERIAL NO. 309597 BATCH NO. 9070752. IT WAS REPORTED THAT DURING USE OF THE SYRINGE 1ML S/T W/NDL 26X5/8 RB THE NEEDLES WERE DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENT STATES A LOT OF THE NEEDLES USED TO INJECT THE MEDICATION WERE DEFECTIVE AND NOW SHE IS SHORT ABOUT A WEEKS WORTH. IT IS UNKNOWN IF THE PATIENT STILL HAS THE PENS ON HAND. IT IS ALSO UNKNOWN IF A DOSE WAS MISSED. EXPIRATION DATE IS UNKNOWN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053262 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