BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ HUBER SAFETY INFUSION SET

    MDR report key: 1060839 · Received June 16, 2008

    Report

    Report Number
    2032582-2008-00002
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Date of Event
    May 18, 2008
    Report Date
    June 16, 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 CUSTOMER COMPLAINS THAT THE LUER CONNECTION (TUBE/ADAPTOR) IS LEAKING. CYTOSTATIC DRUG DROPPED OUT. RECEIVED: ONE ENVELOPE CONTAINING THE FOLLOWING: THE COMPLAINT UNIT FROM SH20-75 LOT UA85 SAMPLE WAS RECEIVED DISPLAYING THE LUER CRACK. NEEDLE WAS STILL ATTACHED TO THE INFUSION EXTENSION LINE SET. EVALUATION: THE RETURNED SAMPLE WAS INSPECTED AND THE CRACK WAS CONFIRMED. CRACK RUNS THE LENGTH OF THE LUER. THE LINE SET WAS RETURNED STILL CONNECTED TO A CODAN EXTENSION LINE SET. THE CODAN EXTENSION LINE SET MALE CONNECTING LUER WAS EVALUATED FOR LUER COMPLIANCE. THE LUER MEETS THE ISO SPECIFICATION. HOWEVER, THE LUER IS ON THE HIGH SIDE OF THE SPECIFICATION. CRACKED FEMALE LUER: THE SAMPLE RETURNED WAS FROM SH20-75 LOT UA85. 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: LUER CRACKING: SH20-75, THE FEMALE LUER CRACKED DURING USE. POSSIBLE CAUSES FOR CRACKING INCLUDE: OVER-TIGHTENING. CRACKING DUE TO MATCHING AGAINST A LUER THAT FALLS DIMENSIONALLY ON THE HIGH SIDE OF THE ISO SPECIFICATION. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    IN 2008, CUSTOMER COMPLAINS THAT THE LUER CONNECTION (TUBE/ADAPTER) IS LEAKING. CYTOSTATIC DRUG DROPPED OUT. ENCLOSED THE MALE PART (INFUSION SET CYTO-AD Z/4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1