BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ HUBER SAFETY INFUSION SET

    MDR report key: 1671416 · Received April 28, 2010

    Report

    Report Number
    2032582-2010-00003
    Event Type
    Injury
    Date Received
    April 28, 2010
    Date of Event
    March 30, 2010
    Report Date
    April 28, 2010
    Manufacturer
    PFM MEDICAL, INC
    Product Code
    FMI
    PMA / PMN Number
    K071846
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). EVALUATION: EVALUATED THE SAMPLE RETURNED FROM THE FACILITY. VERIFIED NEEDLE WAS VISIBLY BENT UPWARD. THERE WAS NO VISIBLE POINT DAMAGE. DMR FOR VK78 WAS REVIEWED AND ALL INDICATED THE INSPECTIONS WERE COMPLETED AND IN ORDER. THIS TYPE OF REJECT IS COVERED IN RISK ANALYSIS. CONCLUSION: THE ASSEMBLY IS NOT DEFECTIVE AND IN FULL WORKING CONDITION. A NEEDLE THAT IS BENT WHEN IT IS TAKEN OUT OF THE PACKAGE IS TYPICAL OF THE PACKAGE BEING DAMAGED OR CRUSHED. IT IS RECOMMENDED THAT THE INSTRUCTIONS FOR USE BE REVIEWED WITH THE NURSE TO ENSURE NEEDLES THAT ARE BENT OUT OF THE PACKAGE ARE NOT USED AS THIS MAY BE AN INDICATION OF PRODUCT OR PACKAGE DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED "THE RN USING THE EZ HUBER NEEDLE WAS STUCK UPON DE-ACCESS. THE NEEDLE DID NOT LOCK INTO THE SHUTTER WHEN PULLING THE NEEDLE OUT AND THROUGH THE BASE." NURSE RECEIVED STANDARD WORK-UP FROM THE EMPLOYEE HEALTH DEPARTMENT. BLOOD WORK WAS OBTAINED, AND SHE WILL NEED TO DO A FOLLOW-UP WITH EMPLOYEE HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ HUBER SAFETY INFUSION SET ADMINISTRATION SET FMI PFM MEDICAL, INC VJ05

    Patients

    Seq Age Sex Outcome Treatment
    1 Other