BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCAL ANESTHESIA CUSTOM PACK

    MDR report key: 21734496 · Received March 31, 2025

    Report

    Report Number
    3012307300-2025-03549
    Event Type
    Malfunction
    Date Received
    March 31, 2025
    Date of Event
    March 4, 2025
    Report Date
    April 22, 2025
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BSO
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: EVALUATION CODES UPDATED. NO ACTUAL PRODUCTS WERE RETURNED, BUT WHEN THE MANUFACTURING RECORDS FOR THAT LOT WERE CHECKED, IT WAS FOUND THAT THE COMPONENTS DIFFERED FROM THE PLANNED SPECIFICATIONS. IN THE MANUFACTURING SYSTEM, THE DATE OF THE SPECIFICATION CHANGE WAS CORRECTLY SET AS OCTOBER 1ST. HOWEVER, AS A MANUFACTURING RULE, THE DATE SET AS THE "MANUFACTURING START DATE" WAS SET TAKING INTO ACCOUNT THE MANUFACTURING LEAD TIME AS OF SEPTEMBER 25TH, WHEN THE MANUFACTURING ORDER WAS ISSUED, AND A DATE AFTER OCTOBER 1ST WAS ENTERED AS THE "MANUFACTURING START DATE." SINCE THE COMPONENTS ON THE "MANUFACTURING START DATE" WERE REFLECTED IN THE MANUFACTURING ORDER, THE ORDER WAS ISSUED WITH THE CONTENTS AFTER THE SPECIFICATION CHANGE. SUBSEQUENT INSPECTIONS ALSO FOUND THAT THE CONTENTS AND LABELS MATCHED, AND THE PRODUCT WAS SHIPPED WITHOUT ANY ABNORMALITIES. TO FIX THIS ISSUE THE RULES WERE CHANGED SO THAT THE "MANUFACTURING START DATE" IN THE MANUFACTURING SYSTEM IS THE SAME DAY THE MANUFACTURING ORDER WAS ISSUED.

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CONTENTS WERE DIFFERENT FROM WHAT THE OPERATOR HAD PLANNED. THE CONTENTS WERE TO BE CHANGED FROM LOT: 241119, BUT THE CONTENTS OF LOT: 240952 WHICH HAD BEEN MANUFACTURED BEFORE THAT WERE CHANGED. THIS OCCURRED UPON REMOVAL FROM PACKAGE. THERE WAS NO PATIENT HARM OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933379 LOCAL ANESTHESIA CUSTOM PACK CATHETER, CONDUCTION, ANESTHETIC BSO SMITHS MEDICAL ASD, INC. 240925

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown