BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES

    MDR report key: 17458433 · Received August 4, 2023

    Report

    Report Number
    9617032-2023-01042
    Event Type
    Malfunction
    Date Received
    August 4, 2023
    Date of Event
    July 10, 2023
    Report Date
    August 9, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE LOT #: UNKNOWN. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR GEL ISSUES WAS NOT OBSERVED. ERRONEOUS RESULTS CANNOT BE EVALUATED THROUGH PHOTOS. IN ADDITION, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. COMPLAINTS FOR SAMPLE QUALITY WERE NOT UNDER STATISTICAL CONTROL FOR THE MONTH OF JULY 2023, HOWEVER, FURTHER TESTING COULD NOT BE DONE SINCE A LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES, GEL RESIDUE ON AN UNSPECIFIED NUMBER OF NEEDLES IS CAUSING ERRONEOUS RESULTS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE BEEN HAVING PROBLEMS WITH OUR HEPARIN GEL TUBES FOR THE LAST FEW WEEKS. OUR CHEMISTRY ANALYZERS ARE GIVING WRONG SODIUM VALUES, AFTER INVESTIGATING IT APPEARS THERE IS GEL RESIDUE ON THE NEEDLE. THE MOMENT THE NEEDLE WOULD PIERCE THE GEL WE IMMEDIATELY GET THE WARNING CLOTH DETECTED BECAUSE THE NEEDLE WOULD BE COMPLETELY SEALED BY THE GEL. HOWEVER, WE SAW GEL ON THE NEEDLE AND INSIDE THE SYSTEM ALSO SMALL GEL RESIDUE THAT GAVE THE PROBLEMS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES, GEL RESIDUE ON AN UNSPECIFIED NUMBER OF NEEDLES IS CAUSING ERRONEOUS RESULTS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE BEEN HAVING PROBLEMS WITH OUR HEPARIN GEL TUBES FOR THE LAST FEW WEEKS. OUR CHEMISTRY ANALYZERS ARE GIVING WRONG SODIUM VALUES, AFTER INVESTIGATING IT APPEARS THERE IS GEL RESIDUE ON THE NEEDLE. THE MOMENT THE NEEDLE WOULD PIERCE THE GEL WE IMMEDIATELY GET THE WARNING CLOTH DETECTED BECAUSE THE NEEDLE WOULD BE COMPLETELY SEALED BY THE GEL. HOWEVER, WE SAW GEL ON THE NEEDLE AND INSIDE THE SYSTEM ALSO SMALL GEL RESIDUE THAT GAVE THE PROBLEMS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1660442 BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown