BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2E (EDTA) 7.2MG

    MDR report key: 20311005 · Received September 26, 2024

    Report

    Report Number
    9617032-2024-01536
    Event Type
    Malfunction
    Date Received
    September 26, 2024
    Date of Event
    August 29, 2024
    Report Date
    September 3, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903688611
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT#: 4081494 D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). D4. MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2025 H4. DEVICE MANUFACTURE DATE: 21-MAR-2024 D4. MEDICAL DEVICE LOT#: 4003731 D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). D4. MEDICAL DEVICE EXPIRATION DATE: 30-APR-2025 H4. DEVICE MANUFACTURE DATE: 03-JAN-2024 INVESTIGATION SUMMARY: MATERIAL #: 368861 LOT/BATCH #: 4081494, 4072651, 4003731 BD RECEIVED 5 SAMPLES OF LOT 4072651 AND 14 USED CLOSURES FOR INVESTIGATION. THE USED CLOSURES WERE REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE OF CORING WITH THE INCIDENT LOT WAS NOT OBSERVED. THE CUSTOMER SAMPLES WERE EVALUATED BY FUNCTIONAL TESTING AND THE INDICATED FAILURE MODE FOR CORING WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. ADDITIONALLY, 10 RETENTION SAMPLES OF EACH LOT FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO CORING AS ALL 30 SAMPLES MET SPECIFICATIONS. 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 CORING. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2E (EDTA) 7.2MG THERE WERE RUBBER STOPPER PARTICLES INSIDE THE TUBE. THE EVENT OCCURRED 100 TIMES ON LOT 4081494, 5 TIMES ON LOT 4072651, AND AN UNSPECIFIED NUMBER OF TIMES ON LOT 4003731. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1098439 BD VACUTAINER® K2E (EDTA) 7.2MG EVACUATED BLOOD COLLECTION TUBE IVD, ANTICOAGULANT JKA BECTON, DICKINSON AND COMPANY (BD) 4072651 50382903688611

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown