BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES

    MDR report key: 18331008 · Received December 14, 2023

    Report

    Report Number
    9617032-2023-01802
    Event Type
    Malfunction
    Date Received
    December 14, 2023
    Date of Event
    November 15, 2023
    Report Date
    February 15, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    00382903684977
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. 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 LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 3114184. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-OCT-2024. H.4. DEVICE MANUFACTURE DATE: 24-APR-2023. D.4. MEDICAL DEVICE LOT #: 3163205. D.4. MEDICAL DEVICE EXPIRATION DATE: 30-NOV-2024. H.4. DEVICE MANUFACTURE DATE: 12-JUN-2023.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR RED CELL HANG UP WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED AND UPON COMPLETION NO ISSUES RELATING TO RED CELL HANG UP WERE OBSERVED. COMPLAINTS FOR SAMPLE QUALITY WERE NOT UNDER STATISTICAL CONTROL FOR THE MONTH OF (B)(6) 2023, ADDITIONAL TESTING WAS PERFORMED: FACTORS THAT MAY CONTRIBUTE TO RED CELL HANG UP WERE EVALUATED THROUGH A CLINICAL STUDY TO VERIFY THE DESIGN OF THE DEVICE MET IT¿S INTENDED USE. NO DIFFICULTIES WERE ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES APPEARED TO EXHIBIT PROPER FILL. BD WAS UNABLE TO DUPLICATE THE CUSTOMER¿S INDICATED FAILURE (RED CELL HANG UP) BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. ALL VISUAL OBSERVATIONS OF BOTH RETENTION AND CONTROL SAMPLES TESTED DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE. ALL TUBES PERFORMED AS EXPECTED. THE RESULT OF THE STUDY SHOWED THAT THE DEVICE PERFORMED AS EXPECTED AND WE WERE UNABLE TO DETERMINE ANY EXTERNAL CONTRIBUTORS TO THIS REPORTED ISSUE. 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 RED CELL HANG UP BASED ON THE PHOTOS PROVIDED. 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 WHEN USING THE BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES HAD NOTICED 50 RED CELL ON TOP OF TUBE AFTER CENTRIFUGATION. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES HAD NOTICED 50 RED CELL ON TOP OF TUBE AFTER CENTRIFUGATION. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1204195 BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 3163205 00382903684977

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown