BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    25 G X 1 IN. BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 6980195 · Received October 26, 2017

    Report

    Report Number
    1213809-2017-00231
    Event Type
    Malfunction
    Date Received
    October 26, 2017
    Date of Event
    October 3, 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
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    SEVEN 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. 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 THAT THERE WAS MIXED PRODUCTS FOUND INSIDE THE PACKAGE OF A 25 G X 1 IN. BD SAFETYGLIDE" NEEDLE PRODUCT. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761814 25 G X 1 IN. BD SAFETYGLIDE¿ NEEDLE SAFETY ENGINEERED HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 6001842 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 Other