BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H10

    MDR report key: 18539870 · Received January 18, 2024

    Report

    Report Number
    1917413-2023-01357
    Event Type
    Malfunction
    Date Received
    January 18, 2024
    Date of Event
    December 20, 2023
    Report Date
    March 13, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903679251
    PMA / PMN Number
    K945952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D1: MEDICAL DEVICE BRAND NAME: BD VACUTAINER® SODIUM FLUORIDE 15MG POTASSIUM OXALATE 12 MG (FX) BLOOD COLLECTION TUBES H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 313604, D4. MEDICAL DEVICE EXPIRATION DATE: 30-SEP-2024, H4. DEVICE MANUFACTURE DATE: 16-MAY-2023, D4. MEDICAL DEVICE LOT #: 3222754, D4. MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2025, H4. DEVICE MANUFACTURE DATE: 10-AUG-2023.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL/CORRECTED INFORMATION: D.4. DEVICE AVAILABLE FOR EVAL: YES. D.4. RETURNED TO MANUFACTURER ON: 29-FEB-2024. H.6. INVESTIGATION SUMMARY: BD RECEIVED FIVE (5) SAMPLES OF EACH LOT AND ONE (1) PHOTO FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR CLOTTED SAMPLES WAS OBSERVED. ADDITIONALLY, THE CUSTOMER SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF DECEMBER 2023. AT THIS TIME, FURTHER TESTING IS NOT INDICATED. 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 HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE OF CLOTTED SAMPLES. 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. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE BD VACUTAINER® SODIUM FLUORIDE 15MG POTASSIUM OXALATE 12 MG (FX) BLOOD COLLECTION TUBES ARE CLOTTING. THE SAMPLES HAD TO BE RECOLLECTED, BUT NO PATIENT IMPACT WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE BD VACUTAINER® SODIUM FLUORIDE 15MG POTASSIUM OXALATE 12 MG (FX) BLOOD COLLECTION TUBES ARE CLOTTING. THE SAMPLES HAD TO BE RECOLLECTED, BUT NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1717294 SEE H10 BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) SEE H10 50382903679251

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown