BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ SHIELDING STERILE IM HYPODERMIC NEEDLE

    MDR report key: 7636578 · Received June 25, 2018

    Report

    Report Number
    1213809-2018-00375
    Event Type
    Malfunction
    Date Received
    June 25, 2018
    Date of Event
    May 4, 2018
    Report Date
    August 1, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    00382903059027
    PMA / PMN Number
    K951254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE SAFETYGLIDE NEEDLE IN AN OPENED PACKAGE WAS RECEIVED, CONFIRMED TO BE FROM BATCH #7121694 (P/N 305902). IT WAS VISUALLY EVALUATED AND THE SHIELD WAS REMOVED. THE CANNULA WAS OBSERVED TO BE COVERED IN WHITE LOOSE PARTICLES ATTACHED TO THE OUTSIDE, WITH AT LEAST ONE LARGER THAN LEVEL 3, WHICH IS REJECTABLE PER PRODUCT SPECIFICATION. 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. PRODUCT DEFECT CONFIRMED BASED ON SAMPLE EVALUATION. QUALITY HAS PREVIOUSLY REVIEWED, EVALUATED AND INVESTIGATED THIS FAILURE MODE. THE FOREIGN MATTER IN QUESTION IS FROM THE PLASTIC MOLDING OPERATION THAT MAKES THE COMPONENTS OF THE NEEDLES. CORRECTIVE ACTION: ADDITIONAL CLEANING. 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 THE BD SAFETYGLIDE SHIELDING STERILE IM HYPODERMIC NEEDLE HAD DEBRIS ALONG THE SHAFT OF THE NEEDLE WHILE MEDICATION WAS BEING DRAWN UP. FOUND DURING USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    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. THE INITIAL REPORTER ALSO NOTIFIED THE FDA. MEDWATCH REPORT # MW5077668.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD SAFETYGLIDE¿ SHIELDING STERILE IM HYPODERMIC NEEDLE HAD DEBRIS ALONG THE SHAFT OF THE NEEDLE WHILE MEDICATION WAS BEING DRAWN UP. FOUND DURING USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475631 BD SAFETYGLIDE¿ SHIELDING STERILE IM HYPODERMIC NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 7121694 00382903059027

    Patients

    Seq Age Sex Outcome Treatment
    1 Other