BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 56 UNITS

    MDR report key: 21662249 · Received March 21, 2025

    Report

    Report Number
    1917413-2025-00298
    Event Type
    Malfunction
    Date Received
    March 21, 2025
    Date of Event
    February 20, 2025
    Report Date
    April 28, 2025
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    30382903679608
    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 RECEIVED ONE PHOTO FOR INVESTIGATION. THE PHOTO WAS VISUALLY EXAMINED AND REVEALED AN AIR BUBBLE AND FOREIGN MATERIAL IN THE GEL FOR BOTH LOT NUMBERS 4222994 AND 4257322. THE EXACT CAUSES FOR THE CUSTOMER¿S FAILURE MODES COULD NOT BE DETERMINED. ADDITIONALLY, 100 RETAINED SAMPLES FROM BOTH LOTS WERE VISUALLY INSPECTED WITH NO ISSUES IDENTIFIED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOTS, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE LOTS 4222994 AND 4257322, FOR THE INDICATED FAILURE MODES: FOREIGN MATTER - NON-BIOLOGICAL AND GEL AIRBUBBLES. 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

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 4222994. D4. MEDICAL DEVICE EXPIRATION DATE: 31-AUG-202.5 H4. DEVICE MANUFACTURE DATE: 09-AUG-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 HEPARINN 56 UNITS THERE WERE GEL BUBBLES IN THE SEPARATOR OF 410 TUBES AND FOREIGN MATTER IN 229 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 HEPARINN 56 UNITS THERE WERE GEL BUBBLES IN THE SEPARATOR OF 410 TUBES AND FOREIGN MATTER IN 229 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336012 BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 56 UNITS BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 4257322 30382903679608

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown