BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE INTEGRA 3ML LL W/NDL 25X5/8 RB

    MDR report key: 8898283 · Received August 15, 2019

    Report

    Report Number
    1213809-2019-00830
    Event Type
    Malfunction
    Date Received
    August 15, 2019
    Date of Event
    July 29, 2019
    Report Date
    September 17, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903052692
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. H3 OTHER TEXT: SEE H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE SYRINGE INTEGRA 3ML LL W/NDL 25X5/8 RB HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT WHEN THE PLUNGER WAS PRESSED, THE CONTENT OF THE SYRINGE BEGAN TO DRIP OUT FROM THE HUB OF THE NEEDLE. VERBATIM: I AM WRITING TO INFORM YOU OF AN INCIDENT THAT OCCURRED RECENTLY WITH A BD SYRINGE. I DREW UP THE VACCINATION AS USUAL, INSERTED THE NEEDLE INTO THE PATIENT'S DELTOID MUSCLE, AND WHEN I PRESSED THE PLUNGER, THE CONTENTS OF THE SYRINGE BEGAN TO DRIP OUT FROM THE HUB OF THE NEEDLE, WHERE IS MEETS THE SYRINGE. THE LOT NUMBER AND EXPIRATION DATE ARE AS FOLLOWS: 7001875, 12/31/2021.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER FACILITY: THE USER FACILITY ADDRESS IS NOT AVAILABLE, THE CORPORATE HEADQUARTERS INFORMATION WAS USED INSTEAD. 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 INTEGRA 3ML LL W/NDL 25X5/8 RB HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT WHEN THE PLUNGER WAS PRESSED, THE CONTENT OF THE SYRINGE BEGAN TO DRIP OUT FROM THE HUB OF THE NEEDLE. VERBATIM: I AM WRITING TO INFORM YOU OF AN INCIDENT THAT OCCURRED RECENTLY WITH A BD SYRINGE. I DREW UP THE VACCINATION AS USUAL, INSERTED THE NEEDLE INTO THE PATIENT'S DELTOID MUSCLE, AND WHEN I PRESSED THE PLUNGER, THE CONTENTS OF THE SYRINGE BEGAN TO DRIP OUT FROM THE HUB OF THE NEEDLE, WHERE IS MEETS THE SYRINGE. THE LOT NUMBER AND EXPIRATION DATE ARE AS FOLLOWS: 7001875, 12/31/2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693436 SYRINGE INTEGRA 3ML LL W/NDL 25X5/8 RB PISTON SYRINGE MEG BECTON DICKINSON MEDICAL SYSTEMS 7001875 30382903052692

    Patients

    Seq Age Sex Outcome Treatment
    1 Other