BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN BLOOD COLLECTION TUBES

    MDR report key: 20952226 · Received December 17, 2024

    Report

    Report Number
    1917413-2024-01213
    Event Type
    Malfunction
    Date Received
    December 17, 2024
    Date of Event
    November 20, 2024
    Report Date
    January 7, 2025
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    PMA / PMN Number
    K945952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. THEREFORE, 90 RETENTION SAMPLES FROM BD INVENTORY OF 4102687 WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE RELATING TO FOREIGN MATTER IN TUBE AND AIR BUBBLES IN GEL WAS NOT OBSERVED. 100 RETENTION SAMPLES FROM BD INVENTORY OF 4137272 WERE EVALUATED BY VISUAL EXAMINATION AND 1 TUBE HAD AIR BUBBLES IN GEL, BUT THE ISSUE RELATING TO FOREIGN MATTER IN TUBE WAS NOT OBSERVED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOTS, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE AIR BUBBLES IN GEL, BUT IS NOT CONFIRMED FOR FOREIGN MATTER IN TUBE. 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

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 4102687. D4. MEDICAL DEVICE EXPIRATION DATE: 30-APR-2025. H4. DEVICE MANUFACTURE DATE: 11-APR-2024. D4. UNIQUE IDENTIFIER (UDI) #:(B)(4). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN BLOOD COLLECTION TUBES FOREIGN MATTER WAS FOUND IN 236 TUBES AND AIR BUBBLES IN GEL WERE FOUND IN 2391 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN BLOOD COLLECTION TUBES FOREIGN MATTER WAS FOUND IN 236 TUBES AND AIR BUBBLES IN GEL WERE FOUND IN 2391 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266230 BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 4137272

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown