BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILKANN 23G CANNULA AND 21G PRE-HOLE NEEDLE

    MDR report key: 12720822 · Received October 29, 2021

    Report

    Report Number
    0001920664-2021-00136
    Event Type
    Injury
    Date Received
    October 29, 2021
    Date of Event
    September 22, 2021
    Report Date
    September 26, 2021
    Manufacturer
    STERIMEDIX LIMITED
    Product Code
    GEA
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF THE COMPLAINT AN IMMEDIATE INVESTIGATION WAS CARRIED OUT. WE HAVE ROOT CAUSED THE ISSUE AND THERE APPEARS TO HAVE POTENTIALLY BEEN AN INTERMITTENT FAILURE IN OUR CURING PROCESS FOR ADHESIVE GLUES. UPON REVIEW OF OUR COMPLAINTS DATABASE FOR THE LAST 3 YEARS WE HAVE UNCOVERED A TREND OF REPORTED COMPLAINTS WHERE THE NEEDLE MAY HAVE POTENTIALLY DETACHED FROM THE HUB. AS THIS IS AN INTERMITTENT FAILURE OUR TESTING IN PROCESS MAY POTENTIALLY HAVE FAILED TO UNCOVER THE REPORTED DEFECT. IT APPEARS THAT THE REPORTED COMPLAINT IS A RESULT OF THE UV CURING PROCESS NOT SUCCESSFULLY COMPLETING ITS CYCLE. THIS CAN FURTHER BE ATTRIBUTED TO HUMAN ERROR RATHER THAN A FAILURE OF THE CURING PROCESS ITSELF. UPON INVESTIGATION IT BECAME APPARENT THAT THE FLOW TESTING CONDUCTED ON 100% OF THE DEVICES WOULD NOT NECESSARILY REVEAL THIS ISSUE. PULL TESTING BECAUSE OF ITS DESTRUCTIVE NATURE IS CONDUCTED ON A SAMPLE BASIS AND THEREFORE NON-COMPLIANT PRODUCT MAY NOT HAVE BEEN DETECTED AT THIS STAGE OF TESTING. SINCE THE REPORT OF THIS COMPLAINT, WE HAVE TAKEN CORRECTIVE ACTION IN ORDER TO ENSURE A ROBUST POKE-YOKE SYSTEM IS IN PLACE TO PREVENT REOCCURRENCE. THE UV CURING SYSTEM HAS BEEN FITTED WITH AN AUDIBLE ALARM THAT ACTIVATES IF THE MACHINE IS NOT LOADED PROPERLY AND THE CYCLE TIME IS NOT COMPLETED. IF THE ALARM ACTIVATES CURRENTLY THE MANAGEMENT ARE INFORMED SO THAT AN INVESTIGATION CAN BE CONDUCTED BEFORE CONTINUING PRODUCTION. WE HAVE ALSO INDEPENDENTLY CONTRACTED AN EXPERIENCED EXTERNAL AUDITOR TO REVIEW THE PROCESS FOR THE POTENTIAL EFFECTIVENESS OF OUR CORRECTIVE ACTION. THE REVIEW HAS NOW BEEN COMPLETED AS OF 01/18/22 THE INITIAL PREVENTATIVE ACTION HAS BEEN DEEMED EFFECTIVE AND RECOMMENDATIONS MADE TO FURTHER MITIGATE THE RISK OF PRODUCT FAILURE. WHILE NOT ALL ACTIONS ARE VIABLE AT THIS TIME, WE HAVE MADE A FURTHER PROCESS MODIFICATION TO REDUCE THE RISK OF PRODUCT FAILURE POST MANUFACTURING BY REDUCING PRODUCT HANDLING. WE BELIEVE THE INVESTIGATION WE HAVE CONDUCTED GIVES US GOOD EVIDENCE THAT OUR CURING PROCESS IS LIKELY TO BE THE ROOT CAUSE OF THE ISSUE. WE HAVE TAKEN ACTION TO PREVENT THE ISSUE CURRENTLY, BUT WE ARE ALSO IMPLEMENTING A FURTHER PREVENTATIVE ACTION. OUR UV CURE PROCESS HAS BEEN RE-ENGINEERED TO REDUCE THE POSSIBILITY OF FAILURE. THIS WILL REDUCE THE CHANCE OF FAILURES FROM HUMAN ERROR AND WILL ALSO ELIMINATE THE ROOT CAUSE OF THE ISSUE. AS NO SAMPLES HAVE BEEN RECEIVED CURRENTLY, WE ARE UNABLE TO EVALUATE THE COMPLAINT SAMPLES AND ARE AWAITING 25 BOXES OF PRODUCT OF THE SAME LOT FOR FURTHER TESTING. THIS INVESTIGATION WILL BE REOPENED IF/WHEN THE 25 BOXES OF PRODUCT OF THE SAME LOT IS RECEIVED AND EVALUATED. THE INVESTIGATION IS CONSIDERED COMPLETE AT THIS TIME. SEE RELATED 0001920664-2021-00131.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED, AND HAS NOT YET BEEN RETURNED. THE INVESTIGATION IS ONGOING. SEE RELATED 0001920664-2021-00131.

    Description of Event or Problem · 1

    A USER FACILITY IN KUWAIT REPORTED HAVING TWO CANNULAS DETACH AND FALL INTO THE FACES OF TWO PATIENTS. ONE OF THE NEEDLES DETACHED AND FULLY ENTERED THE FACE. ON ANOTHER PATIENT, A SECOND DETACHED DURING INJECTION AND WAS REMOVED USING FORCEPS. THIS REPORT IS ON THE SECOND CANNULA AND PATIENT, WHERE THE DETACHED PART OF THE CANNULA WAS ABLE TO BE REMOVED USING FORCEPS. THERE WAS NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1616827 SILKANN 23G CANNULA AND 21G PRE-HOLE NEEDLE INTRADERMAL CANNULA AND NEEDLE GEA STERIMEDIX LIMITED AJ1842A 222

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention