BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CPT¿ NC: 1.0ML FICOLL¿: 2.0ML

    MDR report key: 19537166 · Received June 14, 2024

    Report

    Report Number
    1917413-2024-00523
    Event Type
    Malfunction
    Date Received
    June 14, 2024
    Date of Event
    May 2, 2024
    Report Date
    July 11, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    30382903627821
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD DID NOT RECEIVE RETURNED SAMPLES OR PHOTOS FROM THE CUSTOMER FOR INVESTIGATION OF GLASS BREAKAGE. ADDITIONALLY, INCIDENT LOT # WAS UNABLE TO BE DETERMINED. THEREFORE, REVIEW OF DEVICE HISTORY RECORD AND RETENTION TESTING COULD NOT BE CONDUCTED. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THIS COMPLAINT WILL BE REOPENED TO ASSESS THE LEVEL OF INVESTIGATION NEEDED. THIS COMPLAINT WAS UNABLE TO BE CONFIRMED FOR GLASS BREAKAGE. BD WAS UNABLE TO IDENTIFY A ROOT CAUSE FOR INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    D4. MEDICAL DEVICE LOT#: UNKNOWN D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN H4. DEVICE MANUFACTURE DATE: UNKNOWN LOT NUMBER WAS NOT REPORTED; HOWEVER, POTENTIAL LOT NUMBERS WERE PROVIDED. THE INFORMATION FOR THOSE NUMBERS IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 3142393 D4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2024 H4. DEVICE MANUFACTURE DATE: 01-JUN-2023 D4. MEDICAL DEVICE LOT #: 3230555 D4. MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2024 H4. DEVICE MANUFACTURE DATE: 01-SEP-2023 A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    REPORT 3 OF 4. IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ NC: 1.0ML FICOLL¿: 2.0ML 1 PATIENT SAMPLE BROKE IN THE CENTRIFUGE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    REPORT 3 OF 4 IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ NC: 1.0ML FICOLL¿: 2.0ML 1 PATIENT SAMPLE BROKE IN THE CENTRIFUGE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369400 BD VACUTAINER® CPT¿ NC: 1.0ML FICOLL¿: 2.0ML BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) UNKNOWN 30382903627821

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown