BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 56 UNITS

    MDR report key: 21358371 · Received February 11, 2025

    Report

    Report Number
    1917413-2025-00098
    Event Type
    Malfunction
    Date Received
    February 11, 2025
    Date of Event
    January 16, 2025
    Report Date
    March 1, 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 TWO PHOTOS FOR INVESTIGATION RELATED TO LOT NUMBER 4198325, SHOWING A GEL AIR BUBBLE. ADDITIONALLY, FOR LOT NUMBER 4222994, BD RECEIVED TWO PHOTOS WHICH SHOW FOREIGN MATERIAL IN A TUBE, BUT THE LOT NUMBER IS NOT VISIBLE. THE EXACT CAUSE FOR THE CUSTOMER¿S FAILURE MODE COULD NOT BE DETERMINED FOR EITHER LOT. IN THE RETAINED SAMPLES ANALYSIS, 90 SAMPLES FROM LOT 4198325 WERE VISUALLY INSPECTED, REVEALING SIX SAMPLES WITH AN AIR BUBBLE, AND NO FOREIGN MATERIAL WAS FOUND. SIMILARLY, 100 SAMPLES FROM LOT 4222994 WERE INSPECTED, WITH ONE SAMPLE CONTAINING AN AIR BUBBLE, AND NO FOREIGN MATERIAL WAS OBSERVED. THE ROOT CAUSE ANALYSIS INDICATED THAT AIR BUBBLES IN GEL CAN OCCUR WHEN AIR POCKETS ARE PRESENT IN THE GEL MATERIAL OR IF AIR IS INTRODUCED DURING THE DISPENSING PROCESS. DESPITE THIS, THE DEFECT RATE IS WITHIN ACCEPTABLE QUALITY LIMITS, AND NO FURTHER ACTION IS REQUIRED. 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 BEEN CONFIRMED FOR THE LOT 4198325, FOR THE INDICATED FAILURE MODES: FOREIGN MATTER - NON-BIOLOGICAL AND GEL AIRBUBBLES. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE LOT 4222994, FOR THE INDICATED FAILURE MODE: GEL AIRBUBBLES. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE LOT 4222994, FOR THE INDICATED FAILURE MODE: FOREIGN MATTER - NON-BIOLOGICAL. 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-2025. H4. DEVICE MANUFACTURE DATE: 9-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 950 TUBES AND FOREIGN MATTER WAS FOUND IN 369 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 950 TUBES AND FOREIGN MATTER WAS FOUND IN 369 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793912 BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 56 UNITS BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 4198325 30382903679608

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown