BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SODIUM FLUORIDE 10MG POTASSIUM OXALATE 8 MG (FX) BLOOD TUBES

    MDR report key: 17195676 · Received June 23, 2023

    Report

    Report Number
    1917413-2023-00592
    Event Type
    Malfunction
    Date Received
    June 23, 2023
    Date of Event
    June 7, 2023
    Report Date
    July 17, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903679220
    PMA / PMN Number
    K945952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, ONE HUNDRED (100) RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED RELATING TO COCKED STOPPERS AS ALL SAMPLES MET SPECIFICATIONS. ADDITIONALLY, TEN (10) RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATED TO THE STOPPER. 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 IMPROPER STOPPER FUNCTION. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SODIUM FLUORIDE 10MG POTASSIUM OXALATE 8 MG (FX) BLOOD COLLECTION TUBES WHILE CUSTOMER WAS DRAWING A PATIENT, THE GRAY TOP OF THE VACUTAINER DETACHED FROM THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "CUSTOMER IS REPORTING ISSUE WITH THE RUBBER IN THE CAP. AFFECTED LOT NUMBER 2132112. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER STATED THAT THAT SHE ENCOUNTERED AN ISSUE WITH A GRAY TOP VACUTAINER AT THE SEF ED. WHILE DRAWING A PATIENT, THE GRAY TOP OF THE VACUTAINER DETACHED FROM THE TUBE. UPON LOOKING AT THE CAP, IT WAS NOTICED THAT THERE WAS AN ISSUE WITH THE RUBBER IN THE CAP. DOCUMENTED COMPLAINT AND SENT COMPLAINT QUESTIONNAIRE FOR MORE INFORMATION."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SODIUM FLUORIDE 10MG POTASSIUM OXALATE 8 MG (FX) BLOOD COLLECTION TUBES WHILE CUSTOMER WAS DRAWING A PATIENT, THE GRAY TOP OF THE VACUTAINER DETACHED FROM THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "CUSTOMER IS REPORTING ISSUE WITH THE RUBBER IN THE CAP. AFFECTED LOT NUMBER 2132112. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER STATED THAT THAT SHE ENCOUNTERED AN ISSUE WITH A GRAY TOP VACUTAINER AT THE SEF ED. WHILE DRAWING A PATIENT, THE GRAY TOP OF THE VACUTAINER DETACHED FROM THE TUBE. UPON LOOKING AT THE CAP, IT WAS NOTICED THAT THERE WAS AN ISSUE WITH THE RUBBER IN THE CAP. DOCUMENTED COMPLAINT AND SENT COMPLAINT QUESTIONNAIRE FOR MORE INFORMATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1900114 BD VACUTAINER® SODIUM FLUORIDE 10MG POTASSIUM OXALATE 8 MG (FX) BLOOD TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 367922 2132112 50382903679220

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown