BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES

    MDR report key: 18345588 · Received December 18, 2023

    Report

    Report Number
    1917413-2023-01248
    Event Type
    Malfunction
    Date Received
    December 18, 2023
    Date of Event
    November 21, 2023
    Report Date
    January 8, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    00382903679621
    PMA / PMN Number
    K945952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D10. DEVICE AVAILABLE FOR EVAL- YES D10. RETURNED TO MANUFACTURER ON: 03-JAN-2024 H3. DEVICE RETURNED TO MANUFACTURER- YES H3. DEVICE EVAL BY MANUFACTURER- YES H.6. INVESTIGATION SUMMARY: BD RECEIVED 3 SAMPLES FROM LOT 3163707, 1 SAMPLE FROM LOT 3194811, AND NO SAMPLES FROM LOT 3222767 FOR INVESTIGATION. NO PHOTOS WERE PROVIDED. THE 3 SAMPLES FROM LOT 3163707, AND 1 SAMPLE FROM LOT 3194811 WERE INSPECTED WITH NO ISSUES BEING IDENTIFIED. A DRAW TEST WAS PERFORMED AT THE MANUFACTURING SITE ON THE SAMPLE TUBES. ALL TUBES WERE WITHIN SPECIFICATION LIMITS WITH NO TUBE PUSH OFF OCCURRING. 100 RETENTION SAMPLES FROM EACH LOT WERE VISUALLY INSPECTED WITH NO ISSUES BEING IDENTIFIED. A DRAW TEST WAS PERFORMED AT THE MANUFACTURING SITE ON 10 RETENTION SAMPLE TUBES FROM EACH LOT AFFECTED. ALL TUBES WERE WITHIN SPECIFICATION LIMITS. 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 UNDERFILL AND TUBE PUSH OFF. 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. H3 OTHER TEXT : SEE H. 10.

    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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #:3163707. D.4. MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2024. H.4. DEVICE MANUFACTURE DATE: 12-JUN-2023. D.4. MEDICAL DEVICE LOT #: 3222767. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2024. H.4. DEVICE MANUFACTURE DATE: 10-AUG-2023. D.4. MEDICAL DEVICE LOT #: 3194811. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2024. H.4. DEVICE MANUFACTURE DATE: 13-JUL-2023.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES HAD 88 UNDERFILLING TUBES AND 89 TUBES THAT PUSHED OFF DURING USE. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES HAD 88 UNDERFILLING TUBES AND 89 TUBES THAT PUSHED OFF DURING USE. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67218 BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) SEE H.10 00382903679621

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown