BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES

    MDR report key: 7656234 · Received July 2, 2018

    Report

    Report Number
    9617032-2018-00346
    Event Type
    Malfunction
    Date Received
    July 2, 2018
    Date of Event
    June 13, 2018
    Report Date
    October 9, 2018
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    K022130
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. EVALUATION OF THE CUSTOMER SAMPLES WAS CONDUCTED AND A LACK OF HEPARIN ADDITIVE WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, THE ISSUE RELATING TO MISSING ADDITIVE WAS NOT 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. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH A CAPA. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES OF THIS ISSUE ARE IDENTIFIED. BASED ON THE EVALUATION OF THE CUSTOMER SAMPLES, A LACK OF HEPARIN ADDITIVE WAS OBSERVED. ADDITIONALLY, EVALUATION OF THE RETAIN SAMPLES WAS CONDUCTED AND MISSING ADDITIVE WAS NOT OBSERVED. FURTHER INVESTIGATION HAS BEEN INITIATED THROUGH A CAPA. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES ARE IDENTIFIED. A CAPA HAS BEEN INITIATED TO DOCUMENT FURTHER INVESTIGATION AND ROOT CAUSE ANALYSIS RELATING TO THIS ISSUE. THE INVESTIGATION IS CURRENTLY ON-GOING AND WILL BE UPDATED AS THE POTENTIAL ROOT CAUSE(S) ARE IDENTIFIED. (B)(4). BASED ON AN ASSESSMENT OF SEVERITY AND FREQUENCY, IT WAS DETERMINED THAT A CAPA IS REQUIRED AT THIS TIME IN ORDER TO DETERMINE THE ROOT CAUSE ASSOCIATED WITH THIS ISSUE AND IMPLEMENT CORRECTIVE ACTIONS. THE INVESTIGATION IS CURRENTLY ON-GOING AND FURTHER IMPROVEMENTS WILL BE MADE AS THE POTENTIAL ROOT CAUSE(S) ARE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER LH PST II PLUS BLOOD COLLECTION TUBES EXPERIENCED CLOTTING. IT WAS STATED "AFTER REMOVAL BLOOD COAGULATES IN THE PLASMA TUBE, AFTER CENTRIFUGATION PLASMA IS GEL-LIKE AND NOT LIQUID." NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8120558, EXPIRATION DATE: 2019-10-31, MANUFACTURE DATE: 2018-04-30. MEDICAL DEVICE LOT #: 8050690, EXPIRATION DATE: 2019-08-31, MANUFACTURE DATE: 2018-02-19. 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 BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES EXPERIENCED CLOTTING. IT WAS STATED "AFTER REMOVAL BLOOD COAGULATES IN THE PLASMA TUBE, AFTER CENTRIFUGATION PLASMA IS GEL-LIKE AND NOT LIQUID." NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499135 BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES BLOOD COLLECTION TUBE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other