BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2E 7.2MG PLUS BLOOD COLLECTION TUBE

    MDR report key: 19115742 · Received April 16, 2024

    Report

    Report Number
    9617032-2024-00588
    Event Type
    Malfunction
    Date Received
    April 16, 2024
    Date of Event
    March 22, 2024
    Report Date
    March 26, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    00382903678396
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT#: 4022532. D4. MEDICAL DEVICE EXPIRATION DATE: 05/31/2025. H4. DEVICE MANUFACTURE DATE: 01/22/2024. D4. MEDICAL DEVICE LOT#: UNKNOWN. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.6. INVESTIGATION SUMMARY: LOT # 4022532: BD DID NOT RECEIVE SAMPLES OR PHOTOS FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. 10 RETAINED TUBES WERE DRAWN WITH WATER, USING BD MULTI-SAMPLE NEEDLES AND BD SINGLE-USE HOLDERS. TUBES DREW SATISFACTORILY, AND NO DROPLETS OF WATER WERE VISIBLE IN THE STOPPER WELLS. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BASED ON THE RETAINED SAMPLES TEST RESULTS. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITIONS 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. UNKNOWN LOT #: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THIS COMPLAINT IS UNABLE TO BE CONFIRMED. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THIS COMPLAINT WILL BE REOPENED TO ASSESS THE LEVEL OF INVESTIGATION NEEDED. 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 7.2MG PLUS BLOOD COLLECTION TUBE THERE WAS BLOOD POOLING IN THE STOPPER WELL, THUS RESULTING IN LEAKAGE. THE ISSUE OCCURRED (B)(4) TIMES OVER A 3 MONTH PERIOD. THERE WAS NO REPORT OF IMPACT ON THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691798 BD VACUTAINER® K2E 7.2MG PLUS BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 4022532 00382903678396

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown