BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STA CLEANER SOLUTION

    MDR report key: 7827161 · Received August 29, 2018

    Report

    Report Number
    9710666-2018-00001
    Event Type
    Injury
    Date Received
    August 29, 2018
    Date of Event
    August 15, 2018
    Report Date
    December 20, 2018
    Manufacturer
    DIAGNOSTICA STAGO S.A.S.
    Product Code
    PPM
    UDI-DI
    13607450009733
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DIAGNOSTICA STAGO, INC. IS SUBMITTING THIS REPORT ON BEHALF OF DIAGNOSTICA STAGO S..A.S. TAVERNY (MANUFACTURER) UNDER EXEMPTION NUMBER E2012018. STAGO WILL PROVIDE A FOLLOW-UP REPORT(S) ONCE RELEVANT INFORMATION HAS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    DIAGNOSTICA STAGO, INC. IS SUBMITTING THIS REPORT ON BEHALF OF DIAGNOSTICA STAGO S..A.S. TAVERNY (MANUFACTURER) UNDER EXEMPTION NUMBER E2012018. STAGO INVESTIGATED THE EVENT UNDER CORPORATE COMPLAINT FILE (B)(4). THE CLIENT TOLD US THAT THE INVENTORY SPECIALIST WAS ALLERGIC TO BLEACH AND THAT IF EXPOSED, BURNS WOULD BE THE REACTION. HOWEVER, THE STA CLEANER SOLUTION (REF 00973) DOES NOT CONTAIN BLEACH. THE SUBSTANCES CONTAINED IN THIS PRODUCT ARE IN VERY LOW CONCENTRATION. THEREFORE, IT IS NOT A PRODUCT LABELED DANGEROUS AND A SAFETY DATA SHEET IS NOT MANDATORY ACCORDING TO THE CURRENT REGULATIONS. THIS PRODUCT IS NOT DANGEROUS TO USE. MOREOVER, IT IS THE FIRST TIME THAT THIS TYPE OF EFFECT HAS BEEN REPORTED. INVESTIGATIONS WERE CARRIED OUT REGARDING THE CONDITION OF THE PACKAGING OF THE STA CLEANER SOLUTION. NO PACKAGING ISSUES WERE RECORDED ON THE LOT 202430. WE HAVE CONCLUDED THAT THIS ISSUE IS A TRANSPORTATION PROBLEM AND NOT A PROBLEM RELATED TO THE PACKAGING OF THE STA CLEANER SOLUTION. THE CARRIERS HAVE BEEN ALERTED AND SENSITIZED IN ORDER TO STOP SENDING DAMAGED PACKAGES TO CUSTOMERS. THIS IS AN ISOLATED CASE AND NO CORRECTIVE ACTION WILL BE PUT IN PLACE FOLLOWING THIS MDR. STAGO IS CONCLUDING ITS INVESTIGATION INTO THIS MATTER. NOTE: THERE WERE ISSUES SUBMITTING THIS UPDATE. ATTEMPTS WERE MADE ON 02NOV2018 AND 09NOV2018. TICKETS WERE OPENED, THE LATEST WAS CSH-13822. THIS ENCOMPASSESS AN ISSUE THAT WENT UNRESOLVED SINCE OCT2018 INVOLVING ANOTHER MDR SUBMISSION. THE FINAL RESOLUTION AS PER THE CESUB HELP DESK WAS TO DELETE AND REINSTALL THE ESUBMITTER PROGRAM AND CREATE A NEW SUBMISSION FILE.

    Additional Manufacturer Narrative · 0

    (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4) UNDER EXEMPTION NUMBER E2012018. CORRECTED IMPORTER REPORT NUMBER FROM 2245451-2018-00001 TO 2245451-2018-00003.

    Description of Event or Problem · 0

    ON (B)(6) 2018: STAGO RECEIVED A COMMUNICATION FROM (B)(6), THE CLINICAL LABORATORY EDUCATOR/SAFETY COORDINATOR AT (B)(6). SHE CLAIMS THAT THEY "RECEIVED SOME STA CLEANER SOLUTION FOR THE EVOLUTION/COMPACT THAT LEAKED BECAUSE THE BOX WAS CRUSHED DURING TRANSPORT" AND WHEN HER INVENTORY SPECIALIST WAS DUMPING IT DOWN THE SINK IT SPLASHED ON HIM. IT "BURNED HIS SKIN AND DISCOLORED IT". (B)(6) ALSO STATED THAT THE SHIPPING COMPANY TOOK THE REAGENT OUT OF THE ORIGINAL BOX, PLACED IT INTO AN UNMARKED BOX AND WRAPPED IT WITH PACKING TAPE. ACCORDING TO THE PERSON INVOLVED, "ONE OF THE PACKAGES WAS JUST A ROUND BALL OF PACKING TAPE WITH THE (B)(6) LABEL TAPED ON. IT WAS NOT A BOX WHEN OPENING. EVERYTHING WAS WET. THE BOTTLES WERE PUNCTURED AND CRUSHED." AT FIRST, HE DID NOT KNOW IT WAS LEAKING SINCE THERE WAS NOT ANY PAPERWORK WITH THE ITEM, BUT REALIZED WHAT IT WAS WHEN HE SAW THE BOTTLES. TWO OF THE 4 BOXES SHIPPED WERE DAMAGED. ON 16AUG2018: (B)(6) WAS CONTACTED BY STAGO TO OBTAIN MORE INFORMATION ABOUT THE INCIDENT. ACCORDING TO HER THE PERSON INVOLVED HAS A SEVERE ALLERGY TO BLEACH. IT SHOULD BE NOTED THAT STA CLEANER SOLUTION IS A HIGHLY DILUTE DISINFECTANT WHICH DOES NOT CONTAIN BLEACH. ADDITIONALLY, STAGO DOES NOT HAVE ANY INDICATION THAT GLOVES OR OTHER PPE WERE UTILIZED. SHE STATED, "HE DID NOT GO TO THE ER FOR FURTHER TREATMENT, JUST SELF-TREATED A FEW BLISTERS DUE TO HIS ALLERGY. OTHER THAN THAT ALL IS OK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666951 STA CLEANER SOLUTION STA CLEANER SOLUTION PPM DIAGNOSTICA STAGO S.A.S. 202430 13607450009733

    Patients

    Seq Age Sex Outcome Treatment
    1 Other