BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BACT/ALERT SN REAGENT BOTTLE

    MDR report key: 2393578 · Received January 2, 2012

    Report

    Report Number
    3002769706-2011-00005
    Event Type
    Injury
    Date Received
    January 2, 2012
    Date of Event
    November 29, 2011
    Report Date
    May 29, 2020
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    MDB
    PMA / PMN Number
    K021123
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: THIS SUPPLEMENT REPORT IS BEING SUBMITTED FOLLOWING FDA NOTIFICATION OF A MISSING REPORT. THE INITIAL SUPPLEMENT REPORT WAS INADVERTENTLY LABELED WITH AN INCORRECT REPORT NUMBER (3002769707-2011-00005), AND WAS THEREFORE NOT LINKED APPROPRIATELY TO THE INITIAL REPORT. THE REPORT NUMBER SHOULD HAVE BEEN 3002769707-2011-00005. THE INVESTIGATION DETERMINED THERE WERE NO MANUFACTURING ISSUES RELATED TO THIS LOT. ALL IN PROCESS AND RELEASE TESTING AND INSPECTION RESULTS WERE WITHIN SPECIFICATION AND 100% VISUAL INSPECTION OF RETAINED BOTTLES AT BIOMÉRIEUX DID NOT DETECT ANY DAMAGED BOTTLES. ADDITIONALLY, QUALITY ENGINEERING CONDUCTED A VISUAL INSPECTION ON 300 RETAINED BOTTLES FROM SN LOT # (B)(4), THERE WERE NO COLLAPSED OR BULGED OBSERVED . AFTER MULTIPLE CUSTOMER CONTACTS, THE EXACT DETAILS OF THE EXPOSURE ARE STILL UNKNOWN AND IT IS NOT EXPECTED THAT THE CUSTOMER WILL PROVIDE ANY ADDITIONAL INFORMATION. THE CUSTOMER ONLY REPORTED THE TECHNICIAN SOUGHT MEDICAL TREATMENT, BUT NO INJURY OR ADDITIONAL DETAILS COULD BE PROVIDED BY THE CUSTOMER. BECAUSE THE BOTTLE WAS NOT AVAILABLE TO BE RETURNED, AND WITHOUT ADDITIONAL EVENT DETAILS FROM THE CUSTOMER, NO ADDITIONAL INVESTIGATION COULD BE CONDUCTED. TO DATE THERE HAVE BEEN NO ADDITIONAL EXPOSURE COMPLAINTS RECEIVED AGAINST THIS LOT, AND BASED ON THE INVESTIGATION OF THE RELEASE TESTING AND RETAIN BOTTLES, ADDITIONAL COMPLAINTS ARE NOT EXPECTED. BIOMÉRIEUX HAS ATTEMPTED TO ASCERTAIN THE EVENT DETAILS AT LEAST NINE (9) TIMES WITH THE CUSTOMER, AND HAS COMPLETED AN INVESTIGATION FOR THIS COMPLAINT, AND CONSIDERS THIS COMPLAINT CLOSED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    REPORT NUMBER 3002769706-2011-00005 (SUPPLEMENT 01) WAS SUBMITTED WITH AN ERROR REGARDING THE CORRECTED REPORT NUMBER. REPORT 3002769706-2011-00005 SUPPLEMENT 01 STATED: THIS SUPPLEMENT REPORT IS BEING SUBMITTED FOLLOWING FDA NOTIFICATION OF A MISSING REPORT. THE INITIAL SUPPLEMENT REPORT WAS INADVERTENTLY LABELED WITH AN INCORRECT REPORT NUMBER (3002769707-2011-00005), AND WAS THEREFORE NOT LINKED APPROPRIATELY TO THE INITIAL REPORT. THE REPORT NUMBER SHOULD HAVE BEEN 3002769707-2011-00005. THIS STATEMENT "THE REPORT NUMBER SHOULD HAVE BEEN 3002769707-2011-00005." IS INCORRECT. THE STATEMENT WAS INTENDED TO READ "THE REPORT NUMBER SHOULD HAVE BEEN 3002769706-2011-00005."

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A SN REAGENT BOTTLE EXPLODED ONTO A NURSE WHEN CONNECTING THE BOTTLE TO A VACUTAINER. THE NURSE THEN WENT TO THE EMERGENCY ROOM. THE CUSTOMER REPORTED THEIR VACUTAINER CONSISTS OF A FEMALE LUNAR SYRINGE MADE BY SMITH AND THE SYRINGE IS MADE BY TYCO/KENDALL.. BIOMERIEUX HAS RECEIVED NO ADDITIONAL INFORMATION CONCERNING THESE EVENTS. THE COMPLAINT INDICATED THE INCIDENT OCCURRED ON OR NEAR (B)(6), 2011. FOLLOW-UP CONTACT ATTEMPTS WERE MADE (B)(6), BUT NO ADDITIONAL INFORMATION CONCERNING THE EXPOSURE OR MEDICAL INTERVENTION WAS KNOWN BY THE CUSTOMER. THE SN BOTTLE PACKAGE INSERT CALLS OUT CORRECT SPECIMEN COLLECTION IS EXTREMELY IMPORTANT WHEN OBTAINING BLOOD CULTURE SPECIMENS AND REFERS CUSTOMERS TO FOLLOW CUMITECH 1 C5 FOR PROPER SPECIMEN COLLECTION PROCEDURES, WHICH EXPLICITLY STATES THE MOST IMPORTANT FACTOR IS TO OBTAIN THE BLOOD CULTURE IN ASEPTIC CONDITIONS. THE DIRECT DRAW INOCULATION PROCEDURE IN THE SN PACKAGE INSERT STATES TO MONITOR THE DIRECT DRAW PROCESS CLOSELY AT ALL TIMES DURING COLLECTION TO ASSURE PROPER FLOW IS OBTAINED AND TO AVOID FLOW OF THE BOTTLE CONTENTS INTO THE ADAPTER TUBING. IN STEP 3 PART B, THE INSTRUCTIONS STATE TO COLLECT THE BLOOD USING A BUTTERFLY BLOOD COLLECTION SET AND THE BACT/ALERT BLOOD COLLECTION ADAPTER CAP AS RECOMMENDED BY YOUR INSTITUTION'S APPROVED PROCEDURE. FINALLY, THE SECTION STATES : A CONTAMINATED CULTURE BOTTLE COULD CONTAIN POSITIVE PRESSURE, AND IF USED FOR DIRECT DRAW, MAY CAUSE REFLUX INTO THE PATIENT'S VEIN. CULTURE BOTTLE CONTAMINATION MAY NOT BE READILY APPARENT. MONITOR THE DIRECT DRAW PROCESS CLOSELY TO AVOID REFLUX. DO NOT USE A BOTTLE THAT CONTAINS MEDIA EXHIBITING TURBIDITY, A YELLOW SENSOR, OR EXCESS GAS PRESSURE; THESE ARE SIGNS OF POSSIBLE CONTAMINATION. AN INVESTIGATION HAS BEEN OPENED FOR THIS INCIDENT. THERE HAVE BEEN NO OTHER REPORTS OF 'EXPLOSION' OR EXPOSURE FOR THIS LOT. AS THERE ARE NO SIMILAR COMPLAINTS WITH THIS LOT, THERE IS NO INDICATION THAT THIS ISSUE WILL RECUR. THE EVENT IS REPORTABLE TO THE FDA AS AN ADVERSE EVENT BECAUSE THE CUSTOMER HAD TO SEEK MEDICAL TREATMENT TO DETERMINE EXPOSURE TO THE BOTTLE MEDIA. NO REPORT OF MEDICAL INJURY HAS BEEN REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACT/ALERT SN REAGENT BOTTLE BACT/ALERT SN REAGENT BOTTLE MDB BIOMERIEUX, INC. 1029231

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention