BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROTAINER® TUBES WITH K2E (K2EDTA)

    MDR report key: 15238135 · Received August 16, 2022

    Report

    Report Number
    2618282-2022-00043
    Event Type
    Malfunction
    Date Received
    August 16, 2022
    Date of Event
    July 12, 2022
    Report Date
    September 29, 2022
    Manufacturer
    BD CARIBE LTD.
    Product Code
    JKA
    UDI-DI
    50382903659741
    PMA / PMN Number
    K991702
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL?: YES. D9: RETURNED TO MANUFACTURER ON: 2022-09-14. H.6. INVESTIGATION SUMMARY: BD RECEIVED 33 SAMPLES AND 6 PHOTOS FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. THE PHOTOS WERE EVALUATED AND THE INDICATED FAILURE MODE FOR LEAKING WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, THE CUSTOMER SAMPLES ALONG WITH 50 RETENTION SAMPLES FROM BD INVENTORY, WERE EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL TESTING AND THE ISSUE OF LEAKAGE WAS NOT 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 LEAKAGE BASED ON THE PHOTO EVIDENCE HOWEVER, THE ISSUE WAS NOT OBSERVED IN THE CUSTOMER SAMPLES OR RETAIN TESTING RESULTS. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD MICROTAINER® TUBES WITH K2E (K2EDTA) LEAKING BLOOD FROM THE BOTTOM OF THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "CUSTOMER PROBLEM: CUSTOMER REPORTS A MICROTAINER LEAKING BLOOD FROM THE BOTTOM OF THE TUBE. REF#: (B)(4), LOT#: 2140607".

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD MICROTAINER® TUBES WITH K2E (K2EDTA) LEAKING BLOOD FROM THE BOTTOM OF THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "CUSTOMER PROBLEM: CUSTOMER REPORTS A MICROTAINER LEAKING BLOOD FROM THE BOTTOM OF THE TUBE. REF#: (B)(4), LOT#: 2140607."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1915067 BD MICROTAINER® TUBES WITH K2E (K2EDTA) BLOOD SPECIMEN COLLECTION DEVICE JKA BD CARIBE LTD. 365974 2140607 50382903659741

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown