BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ HUBER SAFETY INFUSION SET

    MDR report key: 1053483 · Received May 28, 2008

    Report

    Report Number
    2032582-2008-00001
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    April 28, 2008
    Report Date
    May 28, 2008
    Manufacturer
    PFM MEDICAL, INC
    Product Code
    FMI
    PMA / PMN Number
    K071846
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE INVESTIGATION CONDUCTED BY VLV ASSOCIATES, INVESTIGATION OF NEEDLE DETACHED FROM THE HOUSING: THE NEEDLE AND HOUSING WERE REMOVED FROM THE JAR AND DECONTAMINATED BY SOAKING IN ISOPROPYL ALCOHOL. THE NEEDLE WAS EXAMINED UNDER A 10 POWER SCOPE FOR THE PRESENCE OF ANY ADHESIVE RESIDUE. ADHESIVE WAS PRESENT. THE HOUSING WAS ALSO EXAMINED UNDER THE SCOPE AND THE PRESENCE OF ADHESIVE WAS ALSO DETECTED. IT APPEARS THAT THE ADHESIVE BOND WAS IN PLACE AND OF PROPER VOLUME. AN ADDITIONAL 25 UNITS WERE TESTED FOR THE NEEDLE TO HOUSING BOND STRENGTH. THE LOWEST PULL OUT VALUE (23.56 LBF) EXCEEDS THE PULL OUT VALUES REQUIRED. THE AVERAGE PULL OUT FORCE WAS 28.83 LBF. THE TYPICAL FORCE REQUIRED TO PULL THE NEEDLE FROM THE SEPTUM IS 3 LBF MAXIMUM. CONCLUSION: THE NEEDLE PULL OUT IS A ONE-TIME OCCURRENCE. THE TEST DATA INDICATES THE PRODUCT WAS PROPERLY ASSEMBLED AND THE BONDS MEET THE PRODUCT REQUIREMENTS AS VALIDATED. INVESTIGATION OF LUER CRACKING: WE ARE UNABLE TO VERIFY THIS COMPLAINT SINCE NO SAMPLE WAS RETURNED. THE SAMPLES RETURNED SUGGEST THAT THE CRACKED LUER WAS FROM LOT UA85 SH20-75. THIS LUER WAS INVESTIGATED PER: TOLERANCE INSPECTION OF THE FEMALE LUER. LUER IS WITHIN THE ISO STANDARDS (ISO 594-2, LOCK FITTINGS). INSPECTION OF RETAIN PRODUCT FROM LOT NO.: UA85 SHOWS THE LUER IS WITHIN THE ISO REQUIREMENTS. HOWEVER, THE LUER IS ON THE UPPER END OF THE TOLERANCES. CONCLUSION: THE FEMALE LUER CRACKED DURING USE. POSSIBLE CAUSES FOR CRACKING INCLUDE: OVER-TIGHTENING. ASSEMBLED TO A NON-LUER MALE LUER CONNECTOR: (MALE LUER IS OUT OF TOLERANCE). S PALOMARES 2008.

    Description of Event or Problem · 1

    LEAKAGE AT CONNECTOR AS WELL AS AT THE HANDLES HAS BEEN REPORTED INDEPENDENTLY BY THREE CUSTOMERS. LEAKAGE OF CHEMOSTATIC DRUGS. ADDITIONALLY ONE NEEDLE DISCONNECTED FROM THE HOUSING AND GOT STRUCK IN THE SEPTUM DURING REMOVAL OF THE NEEDLE AFTER LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ HUBER SAFETY INFUSION SET INTRAVENOUS ADMINISTRATION SET FMI PFM MEDICAL, INC SH19-75/SH20-75 UA83/UA85

    Patients

    Seq Age Sex Outcome Treatment
    1