BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SLIP-TIP DISPOSABLE TUBERCULIN SYRINGE

    MDR report key: 8078545 · Received November 16, 2018

    Report

    Report Number
    1213809-2018-00794
    Event Type
    Malfunction
    Date Received
    November 16, 2018
    Date of Event
    May 8, 2018
    Report Date
    January 22, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096597
    PMA / PMN Number
    K980580
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. 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. ROOT CAUSE DESCRIPTION: NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A MISPRINT OF SCALE MARKINGS ON THE BD¿ SLIP-TIP DISPOSABLE TUBERCULIN SYRINGE, AND THE PLUNGER TIP DETACHED. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A MISPRINT OF SCALE MARKINGS ON THE BD¿ SLIP-TIP DISPOSABLE TUBERCULIN SYRINGE, AND THE PLUNGER TIP DETACHED. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921557 BD¿ SLIP-TIP DISPOSABLE TUBERCULIN SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8005674 30382903096597

    Patients

    Seq Age Sex Outcome Treatment
    1 Other