BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 7070452 · Received November 30, 2017

    Report

    Report Number
    1213809-2017-00360
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    October 24, 2017
    Report Date
    January 18, 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
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE FULL SHELF CARTON (50 UNITS) OF SAFETYGLIDE NEEDLES FROM BATCH #6001842 (P/N 305916) WERE RECEIVED BY BD CANAAN. MIXED PRODUCT DEFECT WAS CONFIRMED. THIS COMPLAINT WAS CONFIRMED TO BE WITHIN THE SCOPE OF A KNOWN ISSUE. QUALITY HAS PREVIOUSLY REVIEWED, EVALUATED AND INVESTIGATED THIS FAILURE MODE. A SITUATIONAL ANALYSIS AND CAPA EXISTS. NO FURTHER ACTION IS REQUIRED AT THIS TIME. 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. REFER TO SITUATIONAL ANALYSIS (B)(4).

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 BY A CONSUMER THAT SOME OF THE 25 G X 1 IN. BD SAFETYGLIDE¿ NEEDLES WERE FOUND TO BE 5/8¿ NEEDLES. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852632 BD SAFETYGLIDE¿ NEEDLE NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 6001842 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 Other