BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIDEX PLUS 28 DAY SOLUTION

    MDR report key: 2440965 · Received February 7, 2012

    Report

    Report Number
    2084725-2012-00004
    Event Type
    Malfunction
    Date Received
    February 7, 2012
    Date of Event
    January 25, 2012
    Report Date
    January 27, 2012
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    LRJ
    PMA / PMN Number
    K923744
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NI

    Additional Manufacturer Narrative · 1

    ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE COMPLAINT HISTORY TRENDING, BATCH RECORD REVIEW, FAILURE MODE EFFECTS ANALYSIS, SYSTEM HAZARD USE AND MISUSE AND HEALTH HAZARD EVALUATION. COMPLAINT HISTORY TRENDING WAS PERFORMED FOR THE PROBLEM CODE "HROTHER" AND "HR-EYE SPLASH" . IT DID NOT REVEAL A SIGNIFICANT TREND. A BATCH RECORD REVIEW COULD NOT BE PERFORMED AS THE PRODUCT AND LOT NUMBER IS UNKNOWN. THE FMEA (FAILURE MODE EFFECTS ANALYSIS) FOR CIDEX PLUS 28 DAY SOLUTION WAS REVIEWED FOR HUMAN EXPOSURE. THE RISK PRIORITY NUMBER (RPN) IS BELOW THE THRESHOLD OF 100. THE SHUMA (SYSTEM HAZARD USE AND MISUSE) FOR CIDEX PLUS 28 DAY SOLUTION WAS ASSESSED AS LOW AS REASONABLY PRACTICABLE. THE HHE (HEALTH HAZARD EVALUATION) FOR CIDEX PLUS 28 DAY SOLUTION WAS REVIEWED FOR SIMILAR ISSUES AND THE HAZARD/RISK INDEX IS NONE/NEGLIGIBLE PER THE IFU AND MSDS, IT IS STATED TO WEAR SUITABLE PROTECTIVE CLOTHING, GLOVES AND EYE PROTECTION WHEN HANDLING THE SOLUTION. SINCE SHE WAS NOT WEARING PROPER PERSONAL PROTECTIVE EQUIPMENT (PPE) AT THE TIME OF THE EVENT, THE SOLUTION SPLASHED ONTO HER EYES AND TEMPLE. THE HCW CONFIRMED THERE WAS NO LID ON THE TRAY. THE HCW WAS ADVISED THAT THE LID NEEDS TO BE ON THE TRAY AT ALL TIMES WITH THE EXCEPTION OF PUTTING ITEMS IN OR REMOVING ITEMS.

    Description of Event or Problem · 1

    A HEALTHCARE WORKER (HCW) REPORTED THAT CIDEX PLUS 28 DAY SOLUTION SPLASHED INTO BOTH OF HER EYES AND ON HER TEMPLE. IT WAS STATED THAT MORE WAS SPLASHED INTO THE LEFT EYE THAN THE RIGHT EYE. SHE IMMEDIATELY RINSED HER EYES WITH WATER AND LATER DID A SECOND RINSING. AFTER SHE RINSED HER EYES, SHE REMOVED HER CONTACT LENSES. THE HCW REPORTED THIS EVENT TO ASP TWO DAYS AFTER THE EVENT OCCURRED. THE HCW DID NOT SEEK MEDICAL ATTENTION. AT THE TIME OF THE REPORTED EVENT, HER EYES WERE STILL RED AND IRRITATED, BUT OTHERWISE FINE. SHE ALSO STATED SHE HAS A SMALL RED AREA ON HER TEMPLE. THE HCW CONFIRMED SHE WAS NOT WEARING ANY PPE. THE HCW STATED SHE WORKS IN A DENTAL OFFICE. SHE WAS REACHING OVER AN UNCOVERED TRAY OF CIDEX PLUS 28 DAY SOLUTION TO OBTAIN A BAG OF TOOTHBRUSHES. THE BAG FELL INTO THE TRAY AND SPLASHED INTO HER EYES AND ON HER TEMPLE. THE HCW CONFIRMED THERE WAS NO LID ON THE TRAY AND THEY "HAVE PROCEDURES AND WILL BE USING THEM." THE MSDS-007 SECTION ON FIRST AID MEASURES REGARDING EYE CONTACT WAS REVIEWED WITH THE HCW. SHE WAS ALSO PROVIDED THE ASP WEBSITE AND THE PATH TO OBTAIN THE MSDS FOR THE CIDEX PLUS 28 DAY SOLUTION. PER THE MSDS-007 , THE HCW WAS ADVISED BY THE ASP CLINICAL NURSE TO SEEK MEDICAL ATTENTION. THE HCW WOULD NOT PROVIDE THE NAME OF THE FACILITY WHERE SHE IS EMPLOYED OR ANY CONTACT INFORMATION. AT THIS TIME, ONLY THE HCW'S FIRST NAME IS KNOWN. IN THE EVENT THE HCW CALLS WITH ADDITIONAL INFORMATION, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIDEX PLUS 28 DAY SOLUTION BIOCIDES SOLUTIONS (LRJ) LRJ ADVANCED STERILIZATION PRODUCTS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1