BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TYVEK® POUCH WITH STERRAD® CHEMICAL INDICATOR

    MDR report key: 7132226 · Received December 19, 2017

    Report

    Report Number
    2084725-2017-00680
    Event Type
    Injury
    Date Received
    December 19, 2017
    Date of Event
    November 30, 2017
    Report Date
    November 30, 2017
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    JOJ
    PMA / PMN Number
    K163598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD (DHR), SYSTEM RISK ANALYSIS (SRA), TRENDING BY LOT NUMBER, RETAINS TESTING, AND FUNCTIONAL ANALYSIS. DHR REVIEW WAS NOT PERFORMED SINCE THE CAUSE OF THE ISSUE WAS DETERMINED TO BE USER ERROR. THE SRA INDICATES THE RISK ASSOCIATED WITH EXPOSURE TO TOXIC OR CORROSIVE MATERIAL IS ¿MEDIUM.¿ COMPLAINT TRENDING BY LOT NUMBER WAS NOT PERFORMED SINCE THE LOT NUMBER PROVIDED WAS NOT A VALID LOT NUMBER. RETAINS ANALYSIS WAS NOT PERFORMED AS THE CAUSE OF THE ISSUE WAS DETERMINED TO BE USER ERROR. FUNCTIONAL ANALYSIS WAS NOT PERFORMED AS THE CAUSE OF THE ISSUE WAS DETERMINED TO BE USER ERROR. THE ASSIGNABLE CAUSE OF THE ISSUE CAN BE ATTRIBUTED TO USER ERROR. THE CUSTOMER ACCIDENTLY LEFT A LOAD ON THE TOP SHELF AND PROCESSED THE LOAD THREE CONSECUTIVE TIMES LIKELY CAUSING RESIDUAL H2O2 ON THE POUCH. AN ASP ACCOUNT MANAGER RE-TRAINED THE STAFF AT THE FACILITY ON PROPER STERRAD USE AND THE IMPORTANCE OF WEARING PPE WHILE HANDLING AND WORKING WITH THE STERRAD. THE ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A FEMALE HEALTH CARE WORKER (HCW) EXPERIENCED A SECOND DEGREE CHEMICAL BURN ON HER RIGHT HAND THUMB WHEN SHE TOUCHED A TYVEK® SELF-SEAL POUCH THAT HAD BEEN PROCESSED IN THREE CONSECUTIVE STERRAD® 100NX CYCLES. THE HCW WAS WEARING GLOVES WHEN SHE INITIALLY REMOVED THE TYVEK® SELF-SEAL POUCH FROM THE STERILIZER AND PLACED THE TYVEK® SELF-SEAL POUCH ON A RACK PRIOR TO PUTTING IT AWAY. SHE LATER REMOVED HER GLOVES AND PICKED UP THE SAME TYVEK® SELF-SEAL POUCH TO PUT IT AWAY, AND THEN EXPERIENCED A BURN ON HER RIGHT THUMB. SHE WASHED THE AFFECTED AREA AND THE SKIN STARTED TO ¿BUBBLE LIKE A BLISTER¿. THE HCW WAS TREATED IN THE EMERGENCY ROOM WITH BACITRACIN OINTMENT, VASELINE GAUZE AND A KLING DRESSING. SHE ALSO RECEIVED FOLLOW-UP AT A BURN CENTER, WHERE SHE CONTINUED WITH THE SAME TOPICAL TREATMENT AND WAS INSTRUCTED NOT TO LIFT ANYTHING. THE AFFECTED AREA MEASURED A LITTLE BIT BIGGER THAN THE SIZE OF A QUARTER, AND THE WHITE AREA PEELED OFF IN APPROXIMATELY FIVE DAYS. THE HCW REPORTED THE SKIN COMPLETELY HEALED, BUT IS STILL VERY SENSITIVE TO TOUCH. THE TOPICAL TREATMENT WAS DISCONTINUED AND THE HCW RETURNED TO WORK ON (B)(6) 2017 AND AT THAT TIME SHE SAID SHE WAS DOING ¿FINE." SERVICE WAS NOT DISPATCHED FOR THE STERRAD® 100NX SINCE THE CUSTOMER ACKNOWLEDGED USER ERROR AS THE CAUSE OF THE H2O2 REACTION. THE HCW STATED THEY HAD INCORRECTLY PLACED THE TYVEK® SELF-SEAL POUCH ON THE TOP SHELF OF THE CHAMBER MAKING IT DIFFICULT TO SEE WHICH LEAD TO THEM LEAVING IT IN FOR TWO ADDITIONAL CYCLES. SHE STATED SHE DID NOT NOTICE ANY ABNORMALITIES WHEN REMOVING THE TYVEK® SELF-SEAL POUCH FROM THE UNIT NOR DID SHE NOTICE ANY RESIDUAL H2O2 ON THE TYVEK® SELF-SEAL POUCH WHEN SHE TOUCHED IT. THE CUSTOMER WAS ADVISED TO ALWAYS WEAR PERSONAL PROTECTIVE EQUIPMENT (PPE) WHEN HANDLING ANY PROCESSED ITEMS. BASED ON THE INFORMATION CONTAINED IN THE COMPLAINT AT THE TIME THE REPORTING DETERMINATION WAS MADE, THIS COMPLAINT IS DEEMED REPORTABLE AS A SERIOUS INJURY. THE HCW EXPERIENCED A SECOND DEGREE BURN AND RECEIVED MEDICAL TREATMENT. ALTHOUGH THERE WERE NO REPORTED PRODUCT MALFUNCTIONS, THIS EVENT WAS RELATED TO ¿USER ERROR¿ WHICH RESULTED IN A SERIOUS INJURY. THIS IS TWO OF TWO 3500A REPORTS BEING SUBMITTED FOR THIS SERIOUS INJURY INVOLVING TWO ASP PRODUCTS. PLEASE REFERENCE MANUFACTURER REPORT NUMBERS: 2084725-2017-00679 & 2084725-2017-00680

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909658 TYVEK® POUCH WITH STERRAD® CHEMICAL INDICATOR SELF-SEAL POUCH JOJ ADVANCED STERILIZATION PRODUCTS

    Patients

    Seq Age Sex Outcome Treatment
    1