BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER LITHIUM HEPARINN 75 USP UNITS BLOOD COLLECTION TUBES

    MDR report key: 12350679 · Received August 20, 2021

    Report

    Report Number
    1917413-2021-00775
    Event Type
    Malfunction
    Date Received
    August 20, 2021
    Date of Event
    August 2, 2021
    Report Date
    September 8, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903678841
    PMA / PMN Number
    K945952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT TWO (2) PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR UNDERFILL WITH THE INCIDENT LOT WAS NOT OBSERVED. ONE PHOTO SHOWED THE LEVEL OF LIQUID BELOW THE FILL LINE MARK ON THE LABEL. HOWEVER, THE FILL LINE IS NOT THE MINIMUM DRAW VOLUME. ADDITIONALLY, (B)(4) RETENTION SAMPLES FROM BD INVENTORY 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 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 OF UNDERFILL. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® LITHIUM HEPARINN 75 USP UNITS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THIS EVENT OCCURRED TWICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: HPD CEBU CMT REPORTED 2 COUNTS OF LIHEP TUBE UNDERFILLING. TUBES WERE SENT FROM A DIFFERENT LABORATORY FOR COLLECTION. BD ASSOCIATE HAS SPOKEN TO THE COLLECTING LABORATORY AND CONFIRMED EVACUATED SYSTEM AS THE METHOD OF COLLECTION, AND WHILE THE REPORTED 2 UNDERFILLED LIHEP TUBES WERE COLLECTED TOGETHER WITH OTHER BD TUBES, ALL OTHER TUBES WERE WITHIN ACCEPTABLE FILL RANGE. COLLECTING LABORATORY HAS SENT 7 MORE OTHER LIHEP TUBES THAT ARE BELOW THE FILL LINE BUT WERE CONSIDERED BY HPD CEBU AS WITHIN ACCEPTABLE ((B)(4)) FILL RANGE, WHILE THE 2 REPORTED TUBES WERE BELOW THE (B)(4) MINIMUM LIMIT. CMT OF HPD CEBU ALSO MENTIONED THAT THIS IS NOT THE FIRST TIME THEY HAVE ENCOUNTERED LIHEP TUBES NOT REACHING THE NOMINAL FILL LINE, BUT DID NOT REPORT AS THE USAGE OF THIS SKU HAS LIMITED APPLICATION IN THEIR LABORATORY PRE-COVID TIME; IT IS ONLY VERY RECENTLY THAT THEY FOUND THESE NON-FILLING TO NOMINAL FILL LINE MORE EVIDENT AND MUCH EMPHASIZED DUE TO THE INCREASED COVID-RELATED TESTING USING THE SAME SKU.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® LITHIUM HEPARINN 75 USP UNITS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THIS EVENT OCCURRED TWICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: HPD CEBU CMT REPORTED 2 COUNTS OF LIHEP TUBE UNDERFILLING. TUBES WERE SENT FROM A DIFFERENT LABORATORY FOR COLLECTION. BD ASSOCIATE HAS SPOKEN TO THE COLLECTING LABORATORY AND CONFIRMED EVACUATED SYSTEM AS THE METHOD OF COLLECTION, AND WHILE THE REPORTED 2 UNDERFILLED LIHEP TUBES WERE COLLECTED TOGETHER WITH OTHER BD TUBES, ALL OTHER TUBES WERE WITHIN ACCEPTABLE FILL RANGE. COLLECTING LABORATORY HAS SENT 7 MORE OTHER LIHEP TUBES THAT ARE BELOW THE FILL LINE BUT WERE CONSIDERED BY HPD CEBU AS WITHIN ACCEPTABLE (-10%) FILL RANGE, WHILE THE 2 REPORTED TUBES WERE BELOW THE -10% MINIMUM LIMIT. CMT OF HPD CEBU ALSO MENTIONED THAT THIS IS NOT THE FIRST TIME THEY HAVE ENCOUNTERED LIHEP TUBES NOT REACHING THE NOMINAL FILL LINE, BUT DID NOT REPORT AS THE USAGE OF THIS SKU HAS LIMITED APPLICATION IN THEIR LABORATORY PRE-COVID TIME; IT IS ONLY VERY RECENTLY THAT THEY FOUND THESE NON-FILLING TO NOMINAL FILL LINE MORE EVIDENT AND MUCH EMPHASIZED DUE TO THE INCREASED COVID-RELATED TESTING USING THE SAME SKU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1244404 BD VACUTAINER LITHIUM HEPARINN 75 USP UNITS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 367884 0316375 50382903678841

    Patients

    Seq Age Sex Outcome Treatment
    1