BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SEDITAINER¿ 0.105M 1.25ML BUFFERED SODIUM CITRATE BLOOD COLLECTION TUBES

    MDR report key: 8921643 · Received August 22, 2019

    Report

    Report Number
    9617032-2019-00964
    Event Type
    Malfunction
    Date Received
    August 22, 2019
    Date of Event
    August 5, 2019
    Report Date
    September 4, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903660655
    PMA / PMN Number
    K953994
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR TUBE DAMAGE WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, THE ISSUE RELATING TO TUBE DAMAGE WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING R&D TESTING AT BD, A GLASS TUBE WAS FOUND TO BE BROKEN UPON RECEIPT WITH A BD SEDITAINER¿ 0.105M 1.25ML BUFFERED SODIUM CITRATE BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING R&D TESTING IN, WE OBSERVED A GLASS TUBE THAT WAS RECEIVED AS CRACKED/BROKEN AT THE TUBE TOP (UNDERNEATH THE HEMOGARD¿ CLOSURE).

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING R&D TESTING AT BD, A GLASS TUBE WAS FOUND TO BE BROKEN UPON RECEIPT WITH A BD SEDITAINER¿ 0.105 M 1.25 ML BUFFERED SODIUM CITRATE BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING R&D TESTING IN, WE OBSERVED A GLASS TUBE THAT WAS RECEIVED AS CRACKED/BROKEN AT THE TUBE TOP (UNDERNEATH THE HEMOGARD¿ CLOSURE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714987 BD SEDITAINER¿ 0.105M 1.25ML BUFFERED SODIUM CITRATE BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 9171567 50382903660655

    Patients

    Seq Age Sex Outcome Treatment
    1 Other