BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER PPT PLASMA PREPARATION TUBE K2E 9.0 MG

    MDR report key: 10021209 · Received May 4, 2020

    Report

    Report Number
    1917413-2020-00421
    Event Type
    Malfunction
    Date Received
    May 4, 2020
    Date of Event
    April 13, 2020
    Report Date
    June 9, 2020
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR COLLAPSED TUBES WITH THE INCIDENT LOT 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. NOTE THAT THERE ARE POTENTIALLY VARYING DEGREES OF TUBE COLLAPSE, BASED ON THE TEMPERATURE AND DURATION OF TIME AT ELEVATED TEMPERATURE. MILDLY COLLAPSED TUBES WILL RETAIN VACUUM AND ONLY SHOW MINIMAL DEFORMATION. MILDLY COLLAPSED TUBES WILL DRAW APPROPRIATELY, BUT MAY NOT BE ABLE TO BE PROCESSED ON LABORATORY INSTRUMENTS (E.G. MAY BE SLIGHTLY BOWED AND NO LONGER FIT IN A RACK). AS LONG AS THE VACUUM IS RETAINED AND THE TUBE FILLS APPROPRIATELY, THE TUBE WILL FUNCTION PROPERLY. FULLY COLLAPSED TUBES APPEAR FLATTENED, TWISTED, AND VISIBLY DEFORMED. FULLY COLLAPSED TUBES RETAIN LITTLE OR NO VACUUM AND THEREFORE CANNOT BE DRAWN TO AN APPRECIABLE VOLUME. THESE TUBES ARE EASILY IDENTIFIED BEFORE USE BY THE HEALTHCARE WORKER, SO THERE IS NO POTENTIAL IMPACT TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TUBES WERE DISCOVERED TO BE DEFECTIVE WITH A BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG. THIS OCCURRED ON 10 SEPARATE OCCASIONS PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLEASE BE ADVISED THAT WE HAVE DISCOVERED DEFORMITIES WITH OUR PEARL CAPPED PPT¿S (BD VACUTAINER PEARL CAP K2E 9.0 MG PLUS 5 ML - #362795). A NUMBER OF TUBES FROM LOT 9241944 EXP ¿ 2020-08-31 HAVE BEEN DETECTED SO FAR.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TUBES WERE DISCOVERED TO BE DEFECTIVE WITH A BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG. THIS OCCURRED ON 10 SEPARATE OCCASIONS PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLEASE BE ADVISED THAT WE HAVE DISCOVERED DEFORMITIES WITH OUR PEARL CAPPED PPT¿S (BD VACUTAINER PEARL CAP K2E 9.0 MG PLUS 5 ML - #362795). A NUMBER OF TUBES FROM LOT 9241944 EXP ¿ 2020-08-31 HAVE BEEN DETECTED SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483607 BD VACUTAINER PPT PLASMA PREPARATION TUBE K2E 9.0 MG BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 9241944

    Patients

    Seq Age Sex Outcome Treatment
    1 Other