BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20977340 · Received December 19, 2024

    Report

    Report Number
    1917413-2024-01249
    Event Type
    Malfunction
    Date Received
    December 19, 2024
    Date of Event
    November 15, 2024
    Report Date
    January 25, 2025
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 100 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND 10 TUBES WERE SELECTED FOR FUNCTIONAL TESTING. NO ISSUES WERE OBSERVED RELATING TO DAMAGED CAPS OR NO FILL AS ALL 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 DAMAGED CAP AND NO FILL. 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

    D2. ADDITIONAL MEDICAL DEVICE TYPE: GIM. G5. MULTIPLE 510K: BK230980, K213670, K231373. 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 DURING USE WITH BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES, THE TUBE CAP WAS CRACKED. THE TUBE WAS REPLACED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING USE WITH BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES, THE TUBE CAP WAS CRACKED. THE TUBE WAS REPLACED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2088368 BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 4073819

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown