BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE 27X1/2 LL ECLIPSE

    MDR report key: 20313191 · Received September 26, 2024

    Report

    Report Number
    3003916417-2024-00224
    Event Type
    Malfunction
    Date Received
    September 26, 2024
    Date of Event
    September 3, 2024
    Report Date
    October 1, 2024
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D.4. OTHER LOT NUMBERS INCLUDE 3304965, 4031535, AND 3304966. OTHER EXPIRATION DATES INCLUDE 2028-10-31AND 2029-01-31. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. OTHER LOT NUMBER DEVICE MANUFACTURE DATES ARE 2023-10-31 AND 2024-01-31.

    Additional Manufacturer Narrative · 0

    VIDEO RECEIVED FOR INVESTIGATION. THROUGH VISUAL INSPECTION, THE SCAN ON THE PRODUCT GENERATED BARCODE FOR ANOTHER MATERIAL. THEREFORE, THE COMPLAINT WAS CONFIRMED. 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. BASED ON THE TEAM¿S INVESTIGATION, THE RESPECTIVE DRAWING FOR THE IMPACTED SKU 30281264, NEEDLE 27X1/2 LL ECLIPSE WAS INADVERTENTLY REVISED AND RELEASED WITH THE INCORRECT BARCODE DURING THE GRAPHIC DESIGN UPDATE. COVERAGE WAS CARRIED OUT TO VERIFY THAT THE OTHER CODES ARE CORRECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEEDLE 27X1/2 LL ECLIPSE BARCODE WAS NOT READABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM PORTUGUESE TO ENGLISH: PRODUCT AGULHA 13X4 ECLIPSE BD CX C/100, FROM LOTS 3304965, 4031535, 3304966 AND 4060057, ON ITS PACKAGING, THE EAN PRINTED IS AS 7891463009142, HOWEVER WHEN BEEPING WITH THE BARCODE COLLECTOR, THE CODE 7891463009371 IS READ, THE SAME BARCODE AS ANOTHER BD PRODUCT - PROBE WITH DISPOSABLE DEVICE 30 X 8.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1831438 BD NEEDLE 27X1/2 LL ECLIPSE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON IND. CIRURGICAS LTDA 4060057

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown