BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (LH) 83 UNITS BLOOD COLLECTION TUBES

    MDR report key: 19701166 · Received July 9, 2024

    Report

    Report Number
    1917413-2024-00615
    Event Type
    Malfunction
    Date Received
    July 9, 2024
    Date of Event
    June 12, 2024
    Report Date
    July 20, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    30382903679622
    PMA / PMN Number
    K945952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. H.3 DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 15-JUL-2024. INVESTIGATION SUMMARY MATERIAL #: 367962. LOT/BATCH #: 4011657. BD RECEIVED 20 SAMPLES FOR INVESTIGATION. THE SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND 10 TUBES WERE SELECTED FOR FUNCTIONAL TESTING. THE INDICATED FAILURE MODE FOR TUBE POP OFF WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, 100 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND 10 TUBES WERE SELECTED FOR FUNCTIONAL TESTING. NO ISSUES WERE OBSERVED RELATING TO TUBE POP OFF 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 TUBE POP OFF. 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.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (LH) 83 UNITS BLOOD COLLECTION TUBES, THE TUBE POPPED OFF THE NEEDLE AS SOON AS THE TUBE WAS INSERTED INTO THE TUBE HOLDER AND PUSHED INTO THE NEEDLE WITH THE GREY RUBBER. NO PATIENT IMPACT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (LH) 83 UNITS BLOOD COLLECTION TUBES, THE TUBE POPPED OFF THE NEEDLE AS SOON AS THE TUBE WAS INSERTED INTO THE TUBE HOLDER AND PUSHED INTO THE NEEDLE WITH THE GREY RUBBER. NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1269294 BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (LH) 83 UNITS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 4011657 30382903679622

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown