BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGE LUER-LOK¿

    MDR report key: 8271807 · Received January 23, 2019

    Report

    Report Number
    1213809-2019-00103
    Event Type
    Malfunction
    Date Received
    January 23, 2019
    Date of Event
    December 31, 2018
    Report Date
    April 15, 2019
    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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: TWO PHOTOS OF ONE LOOSE 3ML SYRINGE WITH AN OPENED BLISTER PACK OF BATCH #7060630 WERE RECEIVED. IT WAS OBSERVED THAT IT IS THE SAME SYRINGE IN BOTH PHOTOS AND THE SCALE MARKING IS SKEWED. THE SCALE MARKINGS BEGIN AT THE 1.5ML MARK AND BECOME MORE VISIBLE AS THEY APPROACH THE 3ML MARK. THIS IS A REJECTABLE CONDITION PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE SCALE MARKING DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. IT IS POSSIBLE THAT THIS DEFECT OCCURRED DURING MACHINE SETUP AND IT IS POSSIBLE THAT FEW SYRINGES WERE NOT PROPERLY SCRAPPED DURING THIS PROCESS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD PLASTIPAK¿ SYRINGE LUER-LOK¿ THERE WAS AN ISSUE WITH SYRINGE MISSING SCALE MARKINGS.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE BD PLASTIPAK¿ SYRINGE LUER-LOK¿ THERE WAS AN ISSUE WITH SYRINGE MISSING SCALE MARKINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65481 BD PLASTIPAK¿ SYRINGE LUER-LOK¿ PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7060630 30382903096580

    Patients

    Seq Age Sex Outcome Treatment
    1 Other