BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK ¿ SYRINGE LUER-LOK¿

    MDR report key: 7899494 · Received September 21, 2018

    Report

    Report Number
    1213809-2018-00613
    Event Type
    Malfunction
    Date Received
    September 21, 2018
    Date of Event
    September 3, 2018
    Report Date
    October 22, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096580
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    FOUR PHOTOS WERE RECEIVED AND EVALUATED. THE PHOTOS DEPICT 3ML 4 PACKAGED SYRINGES. THE PACKAGES HAVE TOP WEB MISALIGNED WITH BOTTOM WEB. THE TOP WEB IS SHIFTED FAR AWAY FROM THE PEEL TO CREATE AND OPENING IN THE SEAL OF THE PACKAGES. AS A SIDE DEFECT, NO BATCH NOR EXPIRATION DATE IS PRINTED ON THE TOP WEB IN THAT AREA. 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. MACHINE LOGS INDICATE TOP WEB DISCONNECTING, WHICH REQUIRED MACHINE ADJUSTMENTS. THE LIKELY ROOT CAUSE FOR THE OPEN SEAL IS A BREAK IN THE TOP WEB DUE TO TOO MUCH TENSION. THE RESULTING RELEASE WOULD SHIFT THE WEB AND SEAL THE PACKAGES INCORRECTLY. FAILURE TO CONTAIN DEFECT. DETECTION CONTROLS ARE IN PLACE TO DETECT THE SHIFT IN THE SEAL AND STOP THE MACHINE. HOWEVER, IT IS APPARENT THAT SOME OF THE DEFECTIVE PACKAGES ENDED UP NOT CLEARED FROM THE LINE AND MIXED WITH THE GOOD PRODUCT. THE PACKAGING SYSTEM HAS BEEN CHANGED SINCE BATCH #8140554 WAS MANUFACTURED DUE TO UNIQUE DEVICE IDENTIFIER IMPLEMENTATION. HOWEVER, THE TOP WEB TENSION SETUP WILL BE RE-EVALUATED TO MINIMIZE THE OCCURRENCE OF THE DEFECT ON THE NEW SYSTEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BOX OF BD PLASTIPAK SYRINGE LUER-LOK WERE NOT SEALED PROPERLY . THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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 THAT A BOX OF BD PLASTIPAK ¿ SYRINGE LUER-LOK¿ WERE NOT SEALED PROPERLY. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738187 BD PLASTIPAK ¿ SYRINGE LUER-LOK¿ HYPODERMIC SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8140554 30382903096580

    Patients

    Seq Age Sex Outcome Treatment
    1 Other