BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER Z (NO ADDITIVE) PLUS URINE TUBE

    MDR report key: 10853744 · Received November 17, 2020

    Report

    Report Number
    9617032-2020-00933
    Event Type
    Malfunction
    Date Received
    November 17, 2020
    Date of Event
    September 28, 2020
    Report Date
    December 4, 2020
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JSL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FOR INVESTIGATION. THEREFORE, TWENTY (20) RETAINED SAMPLES (LOT 0023621) WERE DRAW-TESTED WITH DEIONIZED WATER. THE WATER IS DRAWN FROM A COMPENSATED DRAW APPARATUS. THIS COMPRISES OF A HEADER TANK, WHICH IS CONNECTED VIA TUBING TO A DIRECT DRAW ADAPTER AT THE END, INTO WHICH THE TUBE IS INSERTED. THE LEVEL AT WHICH THE TUBE IS INSERTED INTO THE APPARATUS, IS DETERMINED BY LOCAL ATMOSPHERIC PRESSURE. THIS SIMULATES THE BLOOD DRAWING METHOD. THEN THE DRAWN TUBES ARE WEIGHED ON A CALIBRATED BALANCE. FROM THIS TESTING IT WAS DETERMINED THAT ALL 20 TUBES FROM BOTH LOT NUMBERS DREW WITHIN SPECIFICATION. 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 NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® Z (NO ADDITIVE) PLUS URINE TUBE THE TUBE PUSHED OFF NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED SEVERAL COMPLAINTS AGAINST BD TUBES AND NEEDLES. PUSHED OFF.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® Z (NO ADDITIVE) PLUS URINE TUBE THE TUBE PUSHED OFF NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED SEVERAL COMPLAINTS AGAINST BD TUBES AND NEEDLES. PUSHED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322864 BD VACUTAINER Z (NO ADDITIVE) PLUS URINE TUBE TRANSPORT CULTURE MEDIUM JSL BECTON, DICKINSON AND COMPANY (BD) 0023621

    Patients

    Seq Age Sex Outcome Treatment
    1