BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES

    MDR report key: 18371678 · Received December 21, 2023

    Report

    Report Number
    1917413-2023-01282
    Event Type
    Malfunction
    Date Received
    December 21, 2023
    Date of Event
    November 24, 2023
    Report Date
    January 9, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903678612
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, TEN (10) RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO STOPPER POP OFF AS ALL SAMPLES MET SPECIFICATIONS. ADDITIONALLY, ONE HUNDRED (100) RETENTION SAMPLES WERE VISUALLY EXAMINED, AND NO ISSUES WERE OBSERVED. 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 OF STOPPER POP 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.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES THE STOPPER POPPED OUT OF THE TUBE. THE EVENT OCCURRED 2 TIMES. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS ISSUE WITH RUBBER NOT PUNCTURING PROPERLY WHEN TRYING TO A MANUALLY PIERCE TO PREPARE A HEMATOLOGY SLIDE WHILE USING CAT 367861 LOT 3163679. PER CUSTOMER, THEY ARE TRYING TO PREPARE A MANUAL SLIDE FOR A DIFFERENTIAL BUT THEY ENCOUNTERED ISSUES PIERCING THE RUBBER STOPPER WITH THE DIFF-SAFE DISPENSER AND THE STOPPER POPPING OFF ONCE THEY GET THE DISPENSER THROUGH. WHEN STOPPER POPS OFF, BLOOD LEAKS."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES THE STOPPER POPPED OUT OF THE TUBE. THE EVENT OCCURRED 2 TIMES. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER. -THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS ISSUE WITH RUBBER NOT PUNCTURING PROPERLY WHEN TRYING TO A MANUALLY PIERCE TO PREPARE A HEMATOLOGY SLIDE WHILE USING CAT 367861 LOT 3163679. PER CUSTOMER, THEY ARE TRYING TO PREPARE A MANUAL SLIDE FOR A DIFFERENTIAL BUT THEY ENCOUNTERED ISSUES PIERCING THE RUBBER STOPPER WITH THE DIFF-SAFE DISPENSER AND THE STOPPER POPPING OFF ONCE THEY GET THE DISPENSER THROUGH. WHEN STOPPER POPS OFF, BLOOD LEAKS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278394 BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 3163679 50382903678612

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown