BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K3E 7.2MG PLUS BLOOD COLLECTION TUBES

    MDR report key: 7477957 · Received May 1, 2018

    Report

    Report Number
    9617032-2018-00103
    Event Type
    Malfunction
    Date Received
    May 1, 2018
    Date of Event
    April 9, 2018
    Report Date
    April 11, 2018
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    PJE
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION RESULTS: SUMMARY: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR UNDERFILL WITH THE INCIDENT LOT WAS NOT OBSERVED. EVALUATION AND TESTING OF THE CUSTOMER SAMPLES WAS PERFORMED AND UNDERFILL 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. CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR UNDERFILL WITH THE INCIDENT LOT WAS NOT OBSERVED. FURTHER INVESTIGATION HAS BEEN INITIATED THROUGH CAPA 161123. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES ARE IDENTIFIED. ROOT CAUSE: CAPA 161123 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. RATIONALE: 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 · 1

    IT WAS REPORTED THAT SEVERAL EXTERNAL PRODUCERS FOUND UNDERFILLING WHEN USING BD VACUTAINER® K3E 7.2MG PLUS BLOOD COLLECTION TUBES. IN ADDITION, IT WAS REPORTED THE LABORATORY HAS FOUND THE TUBES TO BE FILLING SLOWER THAN OTHER TUBES. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318447 BD VACUTAINER® K3E 7.2MG PLUS BLOOD COLLECTION TUBES BLOOD COLLECTION TUBE PJE BECTON, DICKINSON AND COMPANY (BD) 7114655

    Patients

    Seq Age Sex Outcome Treatment
    1 Other