BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD 3ML LUER-LOK SYRINGE

    MDR report key: 2660901 · Received July 16, 2012

    Report

    Report Number
    1213809-2012-00005
    Event Type
    Injury
    Date Received
    July 16, 2012
    Date of Event
    June 1, 2012
    Report Date
    July 6, 2012
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: CUSTOMER RETURNED (1) OPENED/USED 3 ML SYRINGE ALONG WITH (2) OPENED EMPTY PACKAGES FROM BEAVER-VISITEC ANTERIOR CHAMBER NEEDLES (LOT 3017527) WITHOUT THE ACTUAL NEEDLES. THE SYRINGE WAS FULLY EVALUATED AND THE TIP OF THE SYRINGES WAS FOUND TO BE PROPERLY MOLDED AND ACCEPTABLE PER ISO STANDARD. NO ISSUES WERE FOUND WITH THE SYRINGE THAT WOULD CONTRIBUTE TO REPORTED CONDITION. SINCE THE NON-BD NEEDLE(S) USED WERE NOT RETURNED FOR OUR REVIEW, WE ARE UNABLE TO CHECK IF INDEED THE NEEDLE USED MET THE ISO SPECIFICATION AND ULTIMATELY PROVIDED SECURE CONNECTION. COMPLAINT WAS UNCONFIRMED, NO ISSUES FOUND WITH THE SYRINGE THAT WOULD CONTRIBUTE TO THE REPORTED CONDITION.

    Description of Event or Problem · 1

    BEAVER-VISITEC NEEDLE DISCONNECTED FROM LUER-LOK SYRINGE AT THE END OF CATARACT SURGERY. THE INCIDENT LED TO A CAPSULAR RUPTURE (WITH IMPLANT REMOVAL AND INSERTION OF A NEW ONE AFTER VITRECTOMY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD 3ML LUER-LOK SYRINGE 3 ML LUER-LOK SYRINGE FMF BECTON DICKINSON 11C03E

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention