BEUDAMED
    FDA Adverse Event Summary report: N

    MONOJECT SYRINGE WITH LUER LOCK-TIP

    MDR report key: 33990 · Received July 10, 1996

    Report

    Report Number
    MW4001399
    Date Received
    July 10, 1996
    Date of Event
    June 21, 1996
    Report Date
    June 21, 1996
    Manufacturer
    SHERWOOD MEDICAL CO
    Product Code
    FMF
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE DLSC REPORT IDENTIFIED THE FOREIGN SUBSTANCE AS CONSISTENT WITH MEDICAL-GRADE SILICONE AND CONTAINING WHAT APPEARD TO BE DIRT CLUMPS. THE FOREIGN SUBSTACNE WAS IN ALL INSTANCES WAS LOCATED INSIDE THE SLEEVE OF THE SYRINGE HARDPACK OR PACKAGE, NOT INSIDE THE BARREL WHERE IT MIGHT COME INTO CONTACT WITH FLUIDS. STATED DIFFERENTLY, ALL THE FOREIGN MATTER WAS EXTERNAL TO THE SYRINGES STERILE FLUID PATHWAY.

    Description of Event or Problem · 1

    CONCLUSIONS AND COMMENTS: THE FOREIGN SUBSTANCE WAS LOCATED INSIDE THE SLEEVE OF THE HARDPACK NOT INSIDE THE BARREL WHERE IT MIGHT COME INTO CONTACT WITH FLUIDS. THE PROBLEM WAS DISCUSSED WITH PRODUCTION PERSONNEL; MORE FREQUENT CLEANING OF AIR LINES WAS SUGGESTED AS A REMEDY. A SEARCH OF COMPLAINT DATABASE DID NOT UNEARTH ANY SIMILAR COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOJECT SYRINGE WITH LUER LOCK-TIP MONOJECT SYRINGE WITH LUER LOCK-TIP FMF SHERWOOD MEDICAL CO NA 348337

    Patients

    Seq Age Sex Outcome Treatment
    1 NA