BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE NEEDLE

    MDR report key: 12344594 · Received August 19, 2021

    Report

    Report Number
    1213809-2021-00581
    Event Type
    Malfunction
    Date Received
    August 19, 2021
    Date of Event
    June 24, 2021
    Report Date
    August 19, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059189
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: ONE PHOTO AND ONE SAFETYGLIDE NEEDLE (P/N 305918) SEALED IN A BLISTERPAK FROM BATCH# 1022693 WAS RECEIVED. THE SAMPLE WAS VISUALLY EVALUATED. IT WAS IMMEDIATELY OBSERVED THROUGH THE PACKAGE THAT THE NEEDLE WAS UNSHIELDED AND HAD PENETRATED THE BOTTOM WEB. UPON OPENING THE PACKAGE AND EXAMINING THE NEEDLE, SCUFF MARKS COULD BE SEEN UNDERNEATH THE NEEDLE HUB WHERE THIS NEEDLE WOULD HAVE TRAVELED THROUGH THE PACKAGER WITHOUT ITS SHIELD. THE OBSERVED CONDITIONS WERE NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR MISSING SHIELD DEFECT IS ASSOCIATED WITH THE NEEDLE SUPPLIER¿S MANUFACTURING PROCESS. THE SAMPLE AND PHOTO WAS FORWARDED TO THE NEEDLE SUPPLIER FOR FURTHER EVALUATION AND INVESTIGATION. FURTHER INVESTIGATION PERFORMED AT BD COLUMBUS SITE. ONE SAMPLE WAS RECEIVED. IT CAME IN AN OPENED PACKAGING BLISTER. VISUAL INSPECTION WAS PERFORMED WITH A 10X MAGNIFIER LENS. IT HAS NO PLASTIC SHIELD. THE SAFETY MECHANISM HAS NOT BEEN ACTIVATED, NEEDLE IS STRAIGHT, NEEDLE POINT HAS NO HOOKS OR ANY OTHER DEFECT. ONE PHOTO WAS PROVIDED. IT SHOWS A PACKAGING BLISTER WITH A NEEDLE INSIDE. THE NEEDLE ASSEMBLY HAS NO PLASTIC SHIELD, TOP PART OF THE NEEDLE WENT THROUGH THE PACKAGING BLISTER BOTTOM WEB. BASED ON THE INVESTIGATION AND WITH THE SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. POTENTIAL ROOT CAUSE IS IT COULD HAVE HAPPENED THAT THE PLASTIC SHIELD WAS NOT ASSEMBLED AT THE ASSEMBLY LINE AND NOT DETECTED IN THE NEXT PROCESSES. VERIFICATION OF THE SHIELDER WAS PERFORMED. THE SETTING AND FIXTURE ALIGNMENT WERE CORRECT. ADDITIONAL PREVENTIVE MEASURES ON THE LIVE NEEDLE REJECTION STATION WERE INSTALLED ON THE MACHINE IN (B)(6) OF 2020 WITH SATISFACTORY TESTING AND VERIFICATION RESULTS. AS THIS BATCH WAS MANUFACTURED AFTER THE INSTALLATION OF THOSE COMPONENTS FURTHER IMPROVEMENT OPPORTUNITIES TO THE MACHINE FOR LIVE NEEDLE DETECTION WILL BE ASSESSED. FURTHERMORE, 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. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. 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 · 1

    IT WAS REPORTED THAT THE BD SAFETYGLIDE¿ NEEDLE PIERCED THROUGH THE BOTTOM WEB OF THE PACKAGING DUE TO HAVING NO SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MISSING SAFETY CAP ON NEEDLE." VIA BD INVESTIGATION: "THE SAMPLE WAS VISUALLY EVALUATED. IT WAS IMMEDIATELY OBSERVED THROUGH THE PACKAGE THAT THE NEEDLE WAS UNSHIELDED AND HAD PENETRATED THE BOTTOM WEB. UPON OPENING THE PACKAGE AND EXAMINING THE NEEDLE, SCUFF MARKS COULD BE SEEN UNDERNEATH THE NEEDLE HUB WHERE THIS NEEDLE WOULD HAVE TRAVELED THROUGH THE PACKAGER WITHOUT ITS SHIELD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1238892 BD SAFETYGLIDE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 305918 1022693 30382903059189

    Patients

    Seq Age Sex Outcome Treatment
    1