BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER LITHIUM HEPARINN (LH) 95 USP UNITS BLOOD COLLECTION TUBES

    MDR report key: 10505315 · Received September 8, 2020

    Report

    Report Number
    1917413-2020-00790
    Event Type
    Malfunction
    Date Received
    September 8, 2020
    Date of Event
    August 18, 2020
    Report Date
    September 9, 2020
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903678865
    PMA / PMN Number
    K945952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FOR INVESTIGATION. THEREFORE, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY DRAW TESTING AND NO ISSUES WERE OBSERVED RELATING TO UNDERFILL 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 NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TUBES ARE UNDER FILLING DURING USE WITH A BD VACUTAINER® LITHIUM HEPARINN (LH) 95 USP UNITS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER CALLED IN AND STATED THAT THE VACUTAINER IS NOT FILLING ALL THE WAY UP TO THE GREEN LINE. THE ITEM NUMBER IS 367886, LOT#: 9220481. SHE STATED THEY NOTICED THIS ISSUE A COUPLE OF MONTHS AGO AND SHE DOES NOT KNOW IF ANY ERRONEOUS RESULTS HAPPENED BECAUSE OF THIS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER STATE: ADDRESS INFORMATION WAS NOT ABLE TO BE OBTAINED. (B)(4) WAS USED AS A PLACE HOLDER BASED ON THE USER AREA CODE. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TUBES ARE UNDER FILLING DURING USE WITH A BD VACUTAINER® LITHIUM HEPARINN (LH) 95 USP UNITS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER CALLED IN AND STATED THAT THE VACUTAINER IS NOT FILLING ALL THE WAY UP TO THE GREEN LINE. THE ITEM NUMBER IS 367886, LOT#: 9220481. SHE STATED THEY NOTICED THIS ISSUE A COUPLE OF MONTHS AGO AND SHE DOES NOT KNOW IF ANY ERRONEOUS RESULTS HAPPENED BECAUSE OF THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970223 BD VACUTAINER LITHIUM HEPARINN (LH) 95 USP UNITS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 367886 9220481 50382903678865

    Patients

    Seq Age Sex Outcome Treatment
    1 Other