BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIDEX® OPA-CONCENTRATE

    MDR report key: 3892930 · Received June 24, 2014

    Report

    Report Number
    2084725-2014-00207
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    April 30, 2014
    Report Date
    June 2, 2014
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MED
    PMA / PMN Number
    K032959
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD/BATCH RECORD REVIEW, COMPLAINT HISTORY WITH FAILURE MODE TRENDING, FAILURE MODE EFFECTS ANALYSIS, SYSTEM HAZARD USE MISUSE ANALYSIS AND HEALTH HAZARD EVALUATION. THE DHR BATCH RECORD REVIEW COULD NOT BE PERFORMED AS THERE WAS NO LOT NUMBER PROVIDED. A REVIEW OF THE COMPLETE HISTORY OF ALL COMPLAINTS FOR THE PRODUCT CIDEX® OPA-C SOLUTIONS AND RELATED PROBLEM CODE SKIN REACTION SHOWED NO OTHER COMPLAINTS BESIDES THIS ONE EVENT. THIS DOES NOT CONSTITUTE A SIGNIFICANT TREND. THE SUPPLIER'S FMEA WAS REVIEWED AND NO ADDITIONAL LABELING MITIGATIONS ARE REQUIRED. THE SHUMA HAS BEEN ASSESSED AS LOW AS REASONABLY PRACTICABLE. THE HHE WAS REVIEWED AND IT WAS NOTED THAT THE CAP HAS A MINIMUM TORQUE SPECIFICATION IN ORDER TO REDUCE THE RISK OF LEAKAGE. THE CAP TIGHTNESS IS A MITIGATION AGAINST LEAKS OF THE CIDEX® OPA-C CHEMICAL. THIS MAY RESULT IN CAPS THAT ARE DIFFICULT TO OPEN MANUALLY. THIS IS THE FIRST COMPLAINT THE ALLEGES INJURY FROM CIDEX® OPA-C CAP. RETAIN EVALUATION WAS NOT PERFORMED BECAUSE NO LOT NUMBER WAS PROVIDED. THE CIDEX® OPA-C IFU DOES NOT SPECIFY THE REQUIREMENT OF ANY TOOLS TO OPEN THE BOTTLE CAP. CIDEX® OPA-C BOTTLES ARE EQUIPPED WITH A TAMPER EVIDENT BOTTLE CAP. THE CAP IS TURNED COUNTER CLOCKWISE TO OPEN. THE SUPPLIER STATED THE BOTTLE CAPS ARE MANUALLY TORQUE WITH THE TORQUE SETTING RECORDED ON EACH BATCH. BATCH RECORD REVIEW WAS NOT PERFORMED BECAUSE NO LOT NUMBER WAS PROVIDED. THE ROOT CAUSE OF THE INJURY COULD NOT BE CONFIRMED DUE TO THE PRODUCT NOT BEING RETURNED FOR INVESTIGATION. ASP WILL CONTINUE TO TRACK AND TREND THIS ISSUE.

    Additional Manufacturer Narrative · 1

    NI

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A HEALTHCARE WORKER (HCW) SUFFERED A HAND LACERATION WHILE OPENING THE CAP OF A BOTTLE OF CIDEX® OPA-C. THE HCW VISITED THE OCCUPATIONAL HEALTH DEPARTMENT AND RECEIVED A FEW SUTURES TO CLOSE THE LACERATION. THE HCW HAS RECOVERED WITHOUT FURTHER COMPLICATION OR INJURY AND IS REPORTED TO BE ¿FINE.¿ THE HCW HAS RETURNED BACK TO WORK. THE CUSTOMER IS NOW USING A WRENCH TO OPEN CIDEX® OPA-C BOTTLE CAPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368629 CIDEX® OPA-CONCENTRATE BIOCIDES SOLUTIONS (MED) MED ADVANCED STERILIZATION PRODUCTS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention