BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2E PLUS BLOOD COLLECTION TUBES

    MDR report key: 18043501 · Received October 31, 2023

    Report

    Report Number
    9617032-2023-01580
    Event Type
    Malfunction
    Date Received
    October 31, 2023
    Date of Event
    October 13, 2023
    Report Date
    November 1, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    00382903682744
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: MATERIAL #: 368274 LOT/BATCH #: 3010341 BD HAD NOT RECEIVED SAMPLES, BUT A PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR STOPPER POP OFF WAS 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 HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE OF STOPPER POP OFF BASED ON THE RETURNED PHOTO. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    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. E.1. INITIAL REPORTER FACILITY NAME: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2E PLUS BLOOD COLLECTION TUBES CAP WAS COMING OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: DEFECT: PIPE CAP COMES OFF QUANTITY: 1 PIECE IMPACT: NO ADVERSE EFFECTS ON PATIENTS AND MEDICAL STAFF CLAIMS: GREEN CLAIMS ARE REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2E PLUS BLOOD COLLECTION TUBES CAP WAS COMING OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: DEFECT: PIPE CAP COMES OFF. QUANTITY: 1 PIECE. IMPACT: NO ADVERSE EFFECTS ON PATIENTS AND MEDICAL STAFF. CLAIMS: GREEN CLAIMS ARE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2092408 BD VACUTAINER® K2E PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 3010341 00382903682744

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown