BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PLASTIC SERUM TUBE WITH RED BD HEMOGARD¿CLOSURE

    MDR report key: 15848398 · Received November 22, 2022

    Report

    Report Number
    9617032-2022-01175
    Event Type
    Malfunction
    Date Received
    November 22, 2022
    Date of Event
    November 4, 2022
    Report Date
    January 24, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    K013971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 2022-12-09. H.6. INVESTIGATION SUMMARY: BD RECEIVED CUSTOMER RETURN SAMPLES AND ONE PHOTO FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR FIBRIN WAS OBSERVED. RETENTION SAMPLES OF THE INCIDENT LOT SELECTED FROM BD INVENTORY WERE INITIALLY TESTED PRIOR TO RECEIVING CUSTOMER RETURN SAMPLES. THE SAMPLES WERE TESTED AND UPON COMPLETION, THE INDICATED FAILURE MODE FOR FIBRIN WAS OBSERVED. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE FIBRIN/FIBRIN MASS BECAUSE THE DEFECT WAS EVIDENT IN THE TESTING OF THE RETENTION LOT SAMPLES. FURTHER TESTING ON CUSTOMER RETURN SAMPLES WAS NOT REQUIRED. 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 CONFIRMED WITH RESPECT TO FIBRIN/FIBRIN CLOTS BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. A COMPLAINT HISTORY REVIEW INDICATED NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS DEFECT ON THIS BATCH NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PLASTIC SERUM TUBE WITH RED BD HEMOGARD¿CLOSURE ARE TURNING THE SERUM INTO ASEMI-SOLID CONSISTENCY AND UNABLE TO DRAW UP A PIPETTE TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ¿COLLECTION TUBES LOT NUMBER 1253837. THEY ARE TURNING THE SERUM INTO ASEMI-SOLID CONSISTENCY AND UNABLE TO DRAW UP A PIPETTE TIP. CUSTOMER HAS SAMPLES THAT CAN BE RETURNED..¿

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PLASTIC SERUM TUBE WITH RED BD HEMOGARD¿CLOSURE ARE TURNING THE SERUM INTO ASEMI-SOLID CONSISTENCY AND UNABLE TO DRAW UP A PIPETTE TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ¿COLLECTION TUBES LOT NUMBER 1253837. THEY ARE TURNING THE SERUM INTO ASEMI-SOLID CONSISTENCY AND UNABLE TO DRAW UP A PIPETTE TIP. CUSTOMER HAS SAMPLES THAT CAN BE RETURNED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309645 BD VACUTAINER® PLASTIC SERUM TUBE WITH RED BD HEMOGARD¿CLOSURE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 1253837

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown