BEUDAMED
    FDA Adverse Event Injury Summary report: N

    API® NIN-2

    MDR report key: 6824790 · Received August 28, 2017

    Report

    Report Number
    3002769706-2017-00252
    Event Type
    Injury
    Date Received
    August 28, 2017
    Report Date
    October 18, 2017
    Manufacturer
    BIOMERIEUX, SA
    Product Code
    JTO
    PMA / PMN Number
    C1 EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BIOMÉRIEUX CONDUCTED AN INTERNAL INVESTIGATION: VERIFICATION OF RETENTION KIT BATCH N°1005510500: CONFORM (NO BREAKAGE OR LEAKAGE OF THE REAGENT). VERIFICATION OF THE PACKAGING: THE PACKAGING IS COMPLIANT IN ACCORDANCE WITH THE INTERNAL MANUFACTURING PROCEDURE: "EACH NIN CORKED VIAL HAD TO BE PLACED IN A AMPULE PROTECTOR THEN PACKAGED POINTING DOWN". VERIFICATION OF THE INFORMATION MENTIONED IN THE PACKAGE INSERT: HAZARD STATEMENTS ARE MENTIONED WITH THE SIGNAL WORD OF SYMBOLS VISIBLE ON THE NIN KIT. THUS, PRECAUTIONARY STATEMENTS ARE ALSO MENTIONED INCLUDING P280 PHRASE: "WEAR PROTECTIVE GLOVES/PROTECTIVE CLOTHING/EYE PROTECTION/FACE PROTECTION". THE P302+P352 PHRASES DESCRIBE THE FIRST AID MEASURES: IF ON SKIN: WASH WITH PLENTY OF SOAP AND WATER. THIS INFORMATION IS ALSO AVAILABLE ON PAGE 9 IN THE WARNINGS AND PRECAUTIONS: "REFER TO THE HAZARD STATEMENTS "H" AND THE PRECAUTIONARY STATEMENTS "P" INDICATED ABOVE." VERIFICATION OF THE INFORMATION MENTIONED IN THE MSDS SHEET REF. (B)(4); SECTION 2 HAZARD IDENTIFICATIONS. 4 FIRST AID MEASURES: SKIN CONTACT: FLUSH WITH COPIOUS AMOUNTS OF WATER FOR AT LEAST 15 MINUTES. REMOVE CONTAMINATED CLOTHING AND SHOES. SUMMON DOCTOR. 8 EXPOSURE CONTROL: HAND: WEAR SUITABLE GLOVES (NITRILE RUBBER). SKIN AND BODY: WEAR SUITABLE PROTECTIVE CLOTHING. IN CONCLUSION, ALL MEASURES ARE IN PLACE IN ORDER TO ADVISE AND ALERT CUSTOMERS TO REAGENT TOXICITY. ACCORDING TO THE INFORMATION AVAILABLE, THIS ISSUE IS PROBABLY DUE TO LEAKAGE OR BREAKAGE OF THE REAGENTS IN THE KIT DURING THE SHIPMENT. CUSTOMERS ARE INSTRUCTED TO CHECK THE APPEARANCE OF THE PRODUCT BEFORE TRANSFERRING IT INTO THE DROPPER-BOTTLES. DOCUMENTS AVAILABLE IN THE TECHNICAL LIBRARY, THAT IS TO SAY THE PACKAGE INSERT V (B)(4) AND THE MSDS SHEET REV. D MENTION INFORMATION LINKED TO HAZARD STATEMENTS (SECTIONS R AND S), PRECAUTIONARY MEASURES (SECTION P), THE FIRST AID MEASURES AND THE BEHAVIOR IN CASE OF EXPOSURE CONTROL, ESPECIALLY TO WEAR SUITABLE PROTECTIVE CLOTHING AND GLOVES. THUS, ACCORDING TO THE INFORMATION AVAILABLE, THIS ISSUE IS PROBABLY DUE TO LEAKAGE OR BREAKAGE OF THE REAGENTS IN THE KIT DURING THE SHIPMENT. IN CONCLUSION, ALL MEASURES ARE IN PLACE IN ORDER TO ADVICE AND ALERT CUSTOMERS TO REAGENT TOXICITY.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) REPORTED TO BIOMÉRIEUX EXPOSURE TO REAGENT LIQUID DUE TO LEAKAGE OF API® NIN-2. THE CUSTOMER REPORTED THAT THEIR FINGERS TURNED PURPLE WHEN OPENING THE BOX, AND THAT THE BOTTOM RIGHT HAND CORNER OF THE WHITE BOX WAS BROWNISH IN COLOR. THE CUSTOMER DID NOT USE THE PRODUCT. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THE EXPOSURE LED TO ANY ADVERSE EVENT RELATED TO THE USER'S STATE OF HEALTH. BIOMÉRIEUX REQUESTED ADDITIONAL INFORMATION FROM THE CUSTOMER AS API® NIN-2 IS TOXIC WHEN IN CONTACT WITH SKIN. THERE HAS BEEN NO RESPONSE FROM THE CUSTOMER. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603782 API® NIN-2 API® NIN-2 JTO BIOMERIEUX, SA 1005510500

    Patients

    Seq Age Sex Outcome Treatment
    1 Other