BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE ECLIPSE 25X1 RB BNS

    MDR report key: 20276012 · Received September 22, 2024

    Report

    Report Number
    2243072-2024-00987
    Event Type
    Malfunction
    Date Received
    September 22, 2024
    Date of Event
    August 27, 2024
    Report Date
    October 21, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    50382903057950
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OUR QUALITY ENGINEER INSPECTED THE PHOTO SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF LABEL CONTENT MISSING WAS NOT CONFIRMED UPON INSPECTION OF THE PHOTO. THE RETURNED PHOTO WAS REVIEWED, CASE LABEL WAS PRINTED PER INSTRUCTION. THEREFORE, THIS IS NOT A NON-CONFORMANCE. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS.

    Additional Manufacturer Narrative · 0

    IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    MATERIAL#: 305795 BATCH NUMBER#: 3142035. IT WAS REPORTED BY CUSTOMER THAT THE NUMBER 305795 (KZ-25025-001A) DOES NOT COME WITH AN EXPIRATION DATE, BUT THE 6,480 PCS OF THE BATCH 3142035 COMES WITH EXPIRATION DATE 2028-05-31. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THIS NUMBER 305795 (KZ-25025-001A) DOES NOT COME WITH AN EXPIRATION DATE, BUT THE 6,480 PCS OF THE BATCH 3142035 COMES WITH EXPIRATION DATE 2028-05-31.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X1 RB BNS LABEL CONTENT MISSING. IT WAS REPORTED BY CUSTOMER THAT THE NUMBER (B)(4); (B)(6) DOES NOT COME WITH AN EXPIRATION DATE, BUT THE (B)(4) PCS OF THE BATCH 3142035 COMES WITH EXPIRATION DATE 2028-05-31 VERBATIM#: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THIS NUMBER (B)(4); (B)(6) DOES NOT COME WITH AN EXPIRATION DATE, BUT THE (B)(6) PCS OF THE BATCH 3142035 COMES WITH EXPIRATION DATE 2028-05-31.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1801449 BD NEEDLE ECLIPSE 25X1 RB BNS BD NEEDLE ECLIPSE 25X1 RB BNS FOZ BECTON DICKINSON 3142035 50382903057950

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown