BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE SYRINGE W/NEEDLE

    MDR report key: 9880054 · Received March 25, 2020

    Report

    Report Number
    1213809-2020-00210
    Event Type
    Malfunction
    Date Received
    March 25, 2020
    Date of Event
    March 9, 2020
    Report Date
    March 9, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903059097
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: MEDICAL DEVICE TYPE: FMF (SYRINGE); FMI (NEEDLE), COMMON DEVICE NAME: PISTON SYRINGE, HYPODERMIC SINGLE LUMEN NEEDLE, PMA / 510(K)#: K980987(SYRINGE); K951254 (NEEDLE). INVESTIGATION SUMMARY: THREE PHOTOS WERE RECEIVED AND EVALUATED. ONE PHOTO DISPLAYED A PURCHASE ORDER LABEL. ONE PHOTO DISPLAYED THE TOP VIEW OF A BLISTER PACK FROM BATCH 9210745 (P/N 305909). ONE PHOTO DISPLAYED THE BOTTOM VIEW OF A FULLY SEALED BLISTER PACK WITH A 3ML SYRINGE AND TWO SAFETYGLIDE NEEDLE ASSEMBLIES INSIDE WITH ONE MISSING A SHIELD AND WAS PROTRUDING THROUGH THE PACKAGE. THE EXTRA NEEDLE ASSEMBLY WAS REJECTABLE PER PRODUCT SPECIFICATION. THE POTENTIAL ROOT CAUSE FOR THE EXTRA PART IN THE PACKAGE IS LACK OF PROPER PART CONTAINMENT ABOVE THE OPEN BLISTERS DURING THE PACKAGING PROCESS. ADDITIONAL BARRIERS WILL BE INSTALLED AROUND THE IDENTIFIED MOVING PARTS HANDLING SYSTEM TO IMPROVE PARTS CONTAINMENT AND TO PREVENT ANY ACCIDENTAL PARTS FROM FALLING INTO THE OPEN BLISTERS DURING THE PACKAGING PROCESS. 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 PRIOR TO USE MISSING SAFETY SHIELD WAS DISCOVERED AND STERILITY MAY BE COMPROMISED WITH A BD SAFETYGLIDE¿ SYRINGE W/NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT NEEDLE IS MISSING THE SAFETY SHIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345031 BD SAFETYGLIDE SYRINGE W/NEEDLE SEE H.10 FMF BECTON DICKINSON MEDICAL SYSTEMS 305909 9210745 30382903059097

    Patients

    Seq Age Sex Outcome Treatment
    1 Other