BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 7060350 · Received November 27, 2017

    Report

    Report Number
    1213809-2017-00279
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    October 26, 2017
    Report Date
    January 2, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059165
    PMA / PMN Number
    K951254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    RESULTS: FIVE SAMPLES WERE RECEIVED BY BD (B)(4) AND CONFIRMED TO BE FROM BATCH #6001842 (P/N 305916). THIS COMPLAINT IS CONFIRMED TO BE WITHIN THE SCOPE OF A KNOWN ISSUE. QUALITY HAS PREVIOUSLY REVIEWED, EVALUATED AND INVESTIGATED THIS FAILURE MODE. NO FURTHER ACTION IS REQUIRED AT THIS TIME. THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO CONFIRM THE CUSTOMERS INDICATED FAILURE 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 CONCLUSION  THE ROOT CAUSE FOR THE CUSTOMERS REPORTED DEFECT WAS CONFIRMED TO BE A MANUFACTURING DEFICIENCY. SITUATIONAL ANALYSIS (B)(4) AND CAPA # (B)(4) WERE OPENED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CONSUMER THAT BD SAFETYGLIDE" NEEDLES WERE FOUND TO BE MORE LIKE 1/2 NEEDLES. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840525 BD SAFETYGLIDE¿ NEEDLE SAFETY ENGINEERED HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 6001842 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 Other