BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER LITHIUM HEPARINN 95 USP UNITS BLOOD COLLECTION TUBES

    MDR report key: 11729493 · Received April 26, 2021

    Report

    Report Number
    1917413-2021-00329
    Event Type
    Malfunction
    Date Received
    April 26, 2021
    Date of Event
    March 30, 2021
    Report Date
    April 27, 2021
    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
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY : BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 10 RETENTION SAMPLES FROM EACH LOT WERE EVALUATED BY FUNCTIONAL 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 LOTS, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD VACUTAINER® LITHIUM HEPARIN 95 USP UNITS BLOOD COLLECTION TUBES WERE UNDERFILLED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MATERIAL NO. 367886, BATCH NO. 0072519, 0167229 AND 9220481. IT IS REPORTED CUSTOMER IS EXPERIENCING UNDER FILLING. VERBIAGE RECEIVED, "HERE ARE THREE ADDITIONAL LOT NUMBERS WHICH THE TUBES ARE NOT FILLING PROPERLY. GREEN LITHIUM HEPARIN 6ML TEST TUBES LOTS 0072519, 0167229, 9220481?"

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0072519, MEDICAL DEVICE EXPIRATION DATE: 2021-08-31, DEVICE MANUFACTURE DATE: 2020-03-12. MEDICAL DEVICE LOT #: 0167229, MEDICAL DEVICE EXPIRATION DATE: 2021-11-30, DEVICE MANUFACTURE DATE: 2020-06-15. MEDICAL DEVICE LOT #: 9220481, MEDICAL DEVICE EXPIRATION DATE: 2021-01-31, DEVICE MANUFACTURE DATE: 2019-08-08.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 BD VACUTAINER® LITHIUM HEPARINN 95 USP UNITS BLOOD COLLECTION TUBES WERE UNDERFILLED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MATERIAL NO. 367886, BATCH NO. 0072519, 0167229 AND 9220481. IT IS REPORTED CUSTOMER IS EXPERIENCING UNDER FILLING. VERBIAGE RECEIVED, - "HERE ARE THREE ADDITIONAL LOT NUMBERS WHICH THE TUBES ARE NOT FILLING PROPERLY. GREEN LITHIUM HEPARIN 6ML TEST TUBES LOTS 0072519, 0167229, 9220481?"".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620912 BD VACUTAINER LITHIUM HEPARINN 95 USP UNITS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 367886 SEE H.10. 50382903678865

    Patients

    Seq Age Sex Outcome Treatment
    1