BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT® FN PLUS

    MDR report key: 8579269 · Received May 3, 2019

    Report

    Report Number
    3002769706-2019-00012
    Event Type
    Malfunction
    Date Received
    May 3, 2019
    Report Date
    October 16, 2019
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    MDB
    UDI-DI
    03573026357917
    PMA / PMN Number
    K121455
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION, BY A CUSTOMER IN SPAIN, OF SAMPLE EXPOSURE WHILE USING ONE BACT/ALERT® FN PLUS BOTTLE WHEN THE BOTTLE FELL TO THE FLOOR AND EXPLODED PRIOR TO REACHING THE SAFETY CABINET. INTERNAL BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. PHOTOS OF THE SUBJECT BOTTLE WERE NOT PROVIDED BY THE CUSTOMER. THE CUSTOMER INDICATED THERE WAS NO SPECIFIC HARM OR INJURY TO ANY EMPLOYEE OR PATIENT DUE TO THIS INCIDENT. THE INVESTIGATION EXAMINED THE BACT/ALERT FN PLUS LOT 4052309 PACKAGING INSPECTIONS, INCLUDING THE QUALITY ACCEPTABLE QUALITY LIMIT INSPECTION DOCUMENTATION, AND ALL THE RESULTS WERE WITHIN SPECIFICATION. QUALITY ASSURANCE SUBSEQUENTLY RELEASED THE LOTS FOR DISTRIBUTION TO THE FIELD ON 16NOV18. 300 RETAINED SAMPLES FROM LOT 4052309 WERE VISUALLY INSPECTED BY THE INVESTIGATOR FOR ANY EVIDENCE OF BROKEN BOTTLES. THERE WERE ZERO BOTTLES FOUND TO BE BROKEN. THE INFORMATION OUTLINED IN THE BACT/ALERT FN PLUS INSTRUCTIONS FOR USE (IFU) INSTRUCTS THE USERS "PRIOR TO USE, THE BACT/ALERT CULTURE BOTTLES SHOULD BE EXAMINED FOR EVIDENCE OF DAMAGE OR DETERIORATION (DISCOLORATION). BOTTLES EXHIBITING EVIDENCE OF DAMAGE, LEAKAGE, OR DETERIORATION SHOULD BE DISCARDED." THE MOST PROBABLE ROOT CAUSE WAS DETERMINED TO BE HANDLING AT THE CUSTOMER'S SITE AS THE BOTTLE WAS DROPPED AND FELL TO THE FLOOR. PLASTIC BACT/ALERT® BOTTLES ARE BREAK RESISTANT, BUT IF DROPPED IT IS POSSIBLE FOR THE BOTTLE TO CRACK ON THE BOTTOM. TRENDING IDENTIFIED NO OTHER BROKEN BOTTLE COMPLAINTS FOR BACT/ALERT® FN PLUS, LOT 4052309. NO ADVERSE TREND WAS IDENTIFIED BY THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    SECTION B4 WAS UPDATED TO 03-MAY-2019 INSTEAD OF THE INITIALLY REPORTED INCORRECT DATE OF 03-APR-2019.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF OPERATOR EXPOSURE IN ASSOCIATION WITH THE BACT/ALERT® FN PLUS BOTTLE (REF 410852, LOT 4052309). THE IMPACTED FN PLUS BOTTLE WAS INOCULATED WITH PATIENT SAMPLE, AND IT WAS A POSITIVE BOTTLE. THE LABORATORY TECHNICIAN TOOK THE BOTTLE FROM THE SYSTEM AND, BEFORE REACHING THE SAFETY CABINET, IT FELL TO THE GROUND AND EXPLODED. PER THE CUSTOMER REPORT, THE BOTTLE HAD NOT BEEN HIT OR DROPPED. THE TECHNICIAN RECEIVED SPLASHES OF THE BLOOD CULTURE. THE TECHNICIAN QUICKLY CHANGED CLOTHES AND TOOK A SHOWER. PER THE CUSTOMER REPORT, SHE HAS NOT SUFFERED ANY INJURY. AT THE TIME OF THIS ASSESSMENT, THE CUSTOMER DID NOT PROVIDE DETAILS REGARDING PATIENT IMPACT. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372635 BACT/ALERT® FN PLUS BACT/ALERT® FN PLUS MDB BIOMERIEUX INC. 4052309 03573026357917

    Patients

    Seq Age Sex Outcome Treatment
    1