BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT: BONE MARROW DA 20/CS

    MDR report key: 5084155 · Received September 17, 2015

    Report

    Report Number
    1030451-2015-00003
    Event Type
    Injury
    Date Received
    September 17, 2015
    Date of Event
    August 13, 2015
    Report Date
    September 14, 2015
    Manufacturer
    MEDICAL ACTION INDUSTRIES
    Product Code
    LWE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF THE (B)(6) 2015 COMPLAINT, MAI OPENED AN INTERNAL COMPLAINT INVESTIGATION UNDER (B)(4). MAI EVALUATED THE TRACKING AND TRENDING DATABASE FOR SIMILAR OCCURRENCES OR RELATED COMPLAINTS, BUT HAD NOT RECEIVED ANY PRIOR COMPLAINTS FOR THIS COMPONENT OR KIT. THIS COMPONENT (LIDOCAINE 30ML GLASS VIAL) IS MANUFACTURED AND SUPPLIED TO MAI BY (B)(4). MAI PLACES THE 30ML LIDOCAINE VIAL INTO A PROTECTIVE POUCH AND ATTACHES IT TO THE EXTERIOR OF THE MAI-ASSEMBLED BONE MARROW KIT AFTER THE KIT HAS BEEN STERILIZED. MAI DID REVISE THE KIT COMPONENTS PER CUSTOMER DISCUSSION AND APPROVAL TO CHANGE THE 30ML GLASS LIDOCAINE VIALS AND INSTEAD IMPLEMENT THE USE OF (2) PLASTIC 20ML LIDOCAINE SOLUTION VIALS. THE HOSPITAL WAS ACCUSTOMED TO USING THESE PARTICULAR STYLE VIALS PREVIOUSLY. THE SUPPLIER, (B)(4), WAS NOTIFIED OF THE RECEIVED COMPLAINT AND WILL BE ADDRESSING THIS ISSUE FURTHER AS WELL BY CONDUCTING AN INTERNAL (B)(4). AT THIS TIME, THEIR INVESTIGATION HAS NOT CONCLUDED OR IDENTIFIED ANY PRODUCT DEFECT INFORMATION.

    Description of Event or Problem · 1

    MEDICAL ACTION INDUSTRIES (MAI) MANUFACTURES A BONE MARROW TRAY CONTAINING LIDOCAINE MANUFACTURED BY (B)(4). ON (B)(6) 2015, MAI RECEIVED A COMPLAINT FROM OHIO STATE UNIVERSITY MEDICAL CENTER REGARDING THE LIDOCAINE. THE HOSPITAL REPORTED THAT THE LIDOCAINE VIAL CAP BLEW OFF THE VIAL WHEN THE TECHNICIAN WAS ADDING AIR TO THE MEDICATION VIAL BEFORE DRAWING OUT THE MEDICATION. AS A RESULT, THE HOSPITAL REPORTED THAT LIDOCAINE SPLASHED INTO THE EYE OF THE LAB TECHNICIAN. THE INJURED EMPLOYEE WAS TREATED WITH A NEUTRALIZING AGENT BY THE MEDICAL CENTER'S EMERGENCY DEPARTMENT, THEN SUBSEQUENTLY RELEASED. THE CUSTOMER WAS UNABLE TO PROVIDE A COMPLAINT LOT NUMBER FOR THE ASSOCIATED PRODUCT. ACCORDING TO THE HOSPITAL, THIS IS THE SECOND INCIDENT INVOLVING LIDOCAINE PROVIDED IN A MAI-MANUFACTURED BONE MARROW TRAY. THE FIRST INCIDENT WAS NOT INITIALLY REPORTED TO MAI BY THE HOSPITAL AND WAS ONLY A COMMENT FROM AN EMPLOYEE THAT STATED THIS LIDOCAINE VIAL WAS A PROBLEM BUT NO INJURY OR FURTHER DETAILS ATTRIBUTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616418 KIT: BONE MARROW DA 20/CS BONE MARROW TRAY LWE MEDICAL ACTION INDUSTRIES 59947B UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention