BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES

    MDR report key: 9354784 · Received November 21, 2019

    Report

    Report Number
    1917413-2019-02366
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    October 29, 2019
    Report Date
    December 18, 2019
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903678568
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE TESTED/EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR STOPPER POP OFF WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    MATERIAL NO. 367856; BATCH NO. 9220449. IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES BLOOD WAS TAKEN INTO A TUBE FINE, BUT 30 SECONDS LATER THE STOPPER POPPED OFF AND BLOOD WENT EVERYWHERE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CALLED REPORTED THAT A NURSE TOOK SOME BLOOD FROM AN IV INTO A SYRINGE AND TRANSFERRED IT INTO A EDTA TUBE, SHE STATES THE VACUUM WAS FINE BUT 30 SECONDS LATER THE STOPPER POPPED OFF AND BLOOD WENT EVERYWHERE. SHE STATES THERE WAS NO EXPOSURE, HOWEVER IT WAS JUST MESSY AND PATIENT HAD TO BE REDRAWN, NO PATIENT IDENTIFIER WAS PROVIDED. THE INCIDENT HAPPENED ON (B)(6) 19. SHE DOES HAVE SAMPLES TO RETURN FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    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 · 1

    MATERIAL NO. 367856, BATCH NO. 9220449. IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES BLOOD WAS TAKEN INTO A TUBE FINE, BUT 30 SECONDS LATER THE STOPPER POPPED OFF AND BLOOD WENT EVERYWHERE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CALLED REPORTED THAT A NURSE TOOK SOME BLOOD FROM AN IV INTO A SYRINGE AND TRANSFERRED IT INTO A EDTA TUBE, SHE STATES THE VACUUM WAS FINE BUT 30 SECONDS LATER THE STOPPER POPPED OFF AND BLOOD WENT EVERYWHERE. SHE STATES THERE WAS NO EXPOSURE, HOWEVER IT WAS JUST MESSY AND PATIENT HAD TO BE REDRAWN, NO PATIENT IDENTIFIER WAS PROVIDED. THE INCIDENT HAPPENED ON (B)(6) 2019. SHE DOES HAVE SAMPLES TO RETURN FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154110 BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 9220449 50382903678568

    Patients

    Seq Age Sex Outcome Treatment
    1 Other