BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ONE USE HOLDER

    MDR report key: 17411277 · Received July 28, 2023

    Report

    Report Number
    1917413-2023-00691
    Event Type
    Malfunction
    Date Received
    July 28, 2023
    Date of Event
    July 4, 2023
    Report Date
    August 3, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903648158
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO SHOWS THE UNIT LABEL OF THE ECLIPSE NEEDLE. ADDITIONALLY, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING, EACH USED TO DRAW 10 VACUTAINER TUBES, AND NO ISSUES WERE OBSERVED RELATING TO SLEEVE LEAKAGE AS ALL SAMPLES MET SPECIFICATIONS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE SLEEVE LEAKAGE. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE 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

    H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN . H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® ONE USE HOLDER HAD LEAKED. THIS EVENT OCCURRED 4 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: LEAKING BLOOD INSIDE THE 364815 ¿I TOOK A BLOOD SAMPLE FROM A PATIENT. ON THE LAST TUBES TAKEN, PRESENCE OF BLOOD LEAKING INSIDE THE PUMP BODY, A PRIORI AT THE LEVEL OF THE SCREWING OF THE VACUTEINER WITH THE PUMP BODY. VACUTEINER REF: LOT 500009923 3032751 EXPIRY DATE 01/31/2028 .

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® ONE USE HOLDER HAD LEAKED. THIS EVENT OCCURRED 4 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: LEAKING BLOOD INSIDE THE 364815 ¿I TOOK A BLOOD SAMPLE FROM A PATIENT. ON THE LAST TUBES TAKEN, PRESENCE OF BLOOD LEAKING INSIDE THE PUMP BODY, A PRIORI AT THE LEVEL OF THE SCREWING OF THE VACUTEINER WITH THE PUMP BODY. VACUTEINER REF: LOT 500009923 3032751. EXPIRY DATE 01/31/2028.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1920731 BD VACUTAINER® ONE USE HOLDER BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) UNKNOWN 50382903648158

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown