BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOSESAVER SYRINGE

    MDR report key: 1205968 · Received October 21, 2008

    Report

    Report Number
    1056186-2008-00003
    Event Type
    Injury
    Date Received
    October 21, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 22, 2008
    Manufacturer
    NIPRO MEDICAL CORPORATION
    Product Code
    FMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORD (DHR): WE IMMEDIATELY STARTED THE PRODUCTION TRACING UPON RECEIVING THE COMPLAINT. THERE ARE TOTALLY 138,000PCS OF DS SYRINGES PRODUCED FOR THIS LOT. WE HAVE REVIEWED ALL THE PRODUCTION RECORDS AND TEST RECORDS FROM THE BEGINNING OF THE PRODUCTION TO THE EX-FACTORY OF THE LAST CONTAINER OF SYRINGES STERILIZED, BUT WE DID NOT FIND ANY ABNORMALITY. CORRECTIVE ACTIONS: THE TECHNICAL DEPARTMENT MAKES THE TRANSFERENCE INSTRUCTION, THE PRODUCTION DEPARTMENT TRAINS AND WORKERS AND FOLLOWS THE REGULATION. ADD ONE INSPECTOR TO BLISTER PACKING PROCESS (FROM ORIGINAL 3 PERSONS TO 4 PERSONS) AND COMPLETELY PICK OUT ALL THE DEFECTIVE PRODUCTS. (SEE SCANNED PAGES).

    Description of Event or Problem · 1

    SYRINGE WITH NEEDLE WAS UNCAPPED INSIDE OF SEALED PACKAGE. CLINICIAN REACHED FOR SYRINGE AND EXPERIENCED A NEEDLESTICK INJURY AT THE BASE OF THE LEFT THUMB. IT IS UNK WHETHER THE NEEDLE WAS CONTAMINATED. EMPLOYEE SOUGHT MEDICAL ATTENTION FOR TREATMENT OF POTENTIAL BLOODBORNE PATHOGENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOSESAVER SYRINGE DISPOSABLE SYRINGE WITH NEEDLE FMF NIPRO MEDICAL CORPORATION JD+01D2238 20070715

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention