BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER

    MDR report key: 21457442 · Received February 25, 2025

    Report

    Report Number
    9617032-2025-00259
    Event Type
    Malfunction
    Date Received
    February 25, 2025
    Date of Event
    January 14, 2025
    Report Date
    February 28, 2025
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    30382903688365
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY - BD RECEIVED TWO PHOTOS FOR INVESTIGATION. THE EVALUATION OF THE ATTACHED PHOTOS SHOWS THAT THE HOLDER HAS SEPARATED. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE LOT NUMBER IS UNKNOWN. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: SEPARATES. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN H4. DEVICE MANUFACTURE DATE: UNKNOWN THE LOT NUMBER IS UNKNOWN; HOWEVER, TWO POTENTIAL LOT NUMBERS WERE PROVIDED. THE INFORMATION FOR THOSE LOT NUMBERS ARE AS FOLLOWS: D4. MEDICAL DEVICE LOT#: 4242711 D4. MEDICAL DEVICE EXPIRATION DATE: 30-SEP-2027 H4. DEVICE MANUFACTURE DATE: 29-AUG-2024 D4. UNIQUE IDENTIFIER (UDI) #:(B)(4). D4. MEDICAL DEVICE LOT#: 4268456 D4. MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2027 H4. DEVICE MANUFACTURE DATE: 24-SEP-2024 D4. UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING ONE BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER, THE NEEDLE SEPARATED WHILE IN THE PATIENT ARM AND THE NEEDLE DRIPPED BLOOD FROM THE NEEDLE END WHEN IT WAS REMOVED FROM THE PATIENT. SAMPLE WAS RECOLLECTED FROM ANOTHER SITE AND THE PATIENT HAD A BRUISE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING ONE BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER, THE NEEDLE SEPARATED WHILE IN THE PATIENT ARM AND THE NEEDLE DRIPPED BLOOD FROM THE NEEDLE END WHEN IT WAS REMOVED FROM THE PATIENT. SAMPLE WAS RECOLLECTED FROM ANOTHER SITE AND THE PATIENT HAD A BRUISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465017 BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON, DICKINSON AND COMPANY (BD) UNKNOWN 30382903688365

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown