BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 5MG/4MG

    MDR report key: 19389049 · Received May 23, 2024

    Report

    Report Number
    1917413-2024-00443
    Event Type
    Malfunction
    Date Received
    May 23, 2024
    Date of Event
    April 26, 2024
    Report Date
    August 16, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    30382903679219
    PMA / PMN Number
    K231237
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D1. MEDICAL DEVICE BRAND NAME: BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE: 100MG POTASSIUM OXALATE: 20MG. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL/CORRECTED INFORMATION: B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT DURING USE WITH THE BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 5MG/4MG, AN UNSPECIFIED NUMBER OF TUBES HAD ISSUES WITH HEMOLYSIS. THERE WAS NO REPORT OF PATIENT IMPACT. D1: MEDICAL DEVICE BRAND NAME: BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 5MG/4MG D4: MEDICAL DEVICE CATALOG #: 367921; BATCH EXPIRATION DATE: 31-MAR-2025; MEDICAL DEVICE LOT #: 3348899; UNIQUE IDENTIFIER (UDI) # (B)(4). G4: PMA/510(K)# K231237. H4: BATCH CREATION DATE: 14-DEC-2023. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT ONE (1) PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR HEMOLYSIS WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, 100 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED AND NO ISSUES WERE OBSERVED RELATING TO HEMOLYSIS AS ALL SAMPLES MET SPECIFICATIONS. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF MAY 2024. 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 IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE OF HEMOLYSIS. 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 THAT DURING USE WITH THE BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE: 100MG POTASSIUM OXALATE: 20MG, AN UNSPECIFIED NUMBER OF TUBES HAD ISSUES WITH HEMOLYSIS. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH THE BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 5MG/4MG, AN UNSPECIFIED NUMBER OF TUBES HAD ISSUES WITH HEMOLYSIS. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656659 BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 5MG/4MG BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 3348899 30382903679219

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown