BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE SPINAL S/SU 27GA 3-1/2IN WHITACRE

    MDR report key: 20235761 · Received September 17, 2024

    Report

    Report Number
    2618282-2024-00126
    Event Type
    Malfunction
    Date Received
    September 17, 2024
    Date of Event
    September 5, 2024
    Report Date
    October 10, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    BSP
    PMA / PMN Number
    K210978
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP MDR FOR CORRECTION. FOLLOWING THE SUBMISSION OF THE INITIAL MDR, IT WAS DETERMINED THAT THE ISSUE REPORTED BY THE CUSTOMER WAS DUE TO AN ISO CHANGE AND THERE WAS NO MALFUNCTION OF BDS PRODUCT. THIS MDR WILL BE VOID.

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    PHOTOS RECEIVED FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT IS OBSERVED IN THE PHOTOS SHELF / CASE CARTONS WITH THE LABEL ADHERED WITH THE CATALOG NUMBER 405079 AND BATCH NUMBER, ALSO PHOTOS SHOW UNUSED AND SEALED NEEDLES IN THEIR BLISTER SHOWING THE TYVEK WITH VARIABLE DATA (CATALOG AND BATCH NUMBER, EXPIRATION DATE, NEEDLE LENGTH). IN THE PHOTOS CAN BE SEEN THE NEEDLE LENGTH IN WHOLE NUMBERS (0.4MM X 90MM) ¿ ENGLISH SIZE AND DECIMAL NUMBERS (0.4MM X 88.9MM) METRIC SIZE. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. IN MAY 2024 IMPLEMENTED TO ALL LABELING LEVELS A UNIT CONVERSION FROM INCH TO MM IN NEEDLE LENGTH CONFIGURATIONS (DECIMAL NUMBERS). THIS CHANGE DID NOT IMPACT THE PRODUCT BECAUSE THE LENGTH OF THE NEEDLE IS THE SAME BUT, REFLECTED IN DECIMAL NUMBERS. BASED ON THE INVESTIGATION RESULTS, NO MANUFACTURING RELATED DEFECTS COULD BE IDENTIFIED AND THEREFORE, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IN ONE PACKAGE IT APPEARS 88.9MM AND IN OTHERS 90MM, IS THIS MEASUREMENT CORRECT? IS IT A CHANGE OF MEASUREMENTS OR AN ERROR IN THE LABEL? IF WE GO BY THE MEASURES EXPRESSED IN THE HEALTH REGISTRATION WE WOULD HAVE THE FOLLOWING: 3.5 INCHES X 2.54 CM = 8.89 CM WOULD BE THE 88.9 MM OF THE SECOND LABEL.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED DATE OF EVENT IDENTIFIED? 05.SEP.2024. PLEASE CONFIRM THE QUANTITY AFFECTED. ALL LOTS OTHER THAN LOT 4113384. IS THERE ANY ISSUE FACED WITH THE PRODUCT OTHER THAN THE LABEL CONTENT INCORRECT? ONLY THE LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1808431 NEEDLE SPINAL S/SU 27GA 3-1/2IN WHITACRE NEEDLE, SPINAL, SHORT TERM BSP BECTON DICKINSON 4079989

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown