BEUDAMED
    FDA Adverse Event Other Summary report: N

    VANISHPOINT SYRINGE

    MDR report key: 634754 · Received September 8, 2005

    Report

    Report Number
    634754
    Event Type
    Other
    Date Received
    September 8, 2005
    Date of Event
    August 23, 2005
    Report Date
    September 8, 2005
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC
    Product Code
    MEG
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NURSE UTILIZED A 3CC, 25G X 5/8 SYRINGE TO DRAW UP PROCRIT 20,000 UNITS FROM A VIAL. NEEDLE RETRACTED AFTER PROCRIT WITHDRAWN FROM VIAL- UNABLE TO USE PROCRIT, PROCRIT WASTED.

    Description of Event or Problem · 1

    AFTER THE CO'S RECEIPT OF THE MEDWATCH REPORT, CO CONTACTED THE FACILITY. THE PRODUCT INVOLVED IN THE INCIDENT WAS NOT AVAILABLE FOR EVALUATION. NOR WAS THE FACILITY ABLE TO PROVIDE ANY PRODUCT ASSOCIATED WITH THE INVOLVED PRODUCT OR EVEN IDENTIFY A LOT NUMBER. THE FACILITY COULD NOT PROVIDE FURTHER DETAILS CONCERNING THE INCIDENT AND BASED ON THE DESCRIPTION GIVEN THE CO IS NOT ABLE TO DETERMINED IF THE PRODUCT MALFUNCTIONED OR IF THE INCIDENT WAS CAUSED BY USER ERROR. FURTHER A REVIEW OF REPORTED INCIDENTS OF THIS TYPE SHOWS THAT THIS TYPE OF ALLEGED INCIDENT IS REPORTED AT A RATE OF LESS THAN .0001%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANISHPOINT SYRINGE RETRACTABLE SYRINGE MEG RETRACTABLE TECHNOLOGIES, INC * 1370310300

    Patients

    Seq Age Sex Outcome Treatment
    1 *