BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    13 X 75 MM X 4.0 ML BD VACUTAINER® PLUS LAVENDER BD HEMOGARD¿ CLOSURE

    MDR report key: 6745511 · Received July 26, 2017

    Report

    Report Number
    1917413-2017-00072
    Event Type
    Malfunction
    Date Received
    July 26, 2017
    Date of Event
    April 21, 2017
    Report Date
    September 11, 2017
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    FKA
    PMA / PMN Number
    K981013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDED LOT# 6253705, EXP DATE 01/31/2018, MANUFACTURE DATE 09/09/2016. RESULTS: CONTAMINATED SAMPLES WERE RECEIVED AT (B)(4) SO NO TESTING COULD BE COMPLETED. THE DHR WAS REVIEWED AND NO ISSUES WERE FOUND. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. CONTAMINATED SAMPLES WERE RECEIVED AT (B)(4) SO NO TESTING COULD BE COMPLETED AT THE MANUFACTURING SITE. THE DHR WAS REVIEWED AND NO ISSUES WERE FOUND. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS CONCLUSION: BASED ON THE INVESTIGATION, THE ROOT CAUSE COULD NOT BE DETERMINED WITHIN THE SCOPE OF THIS EVALUATION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. RESULTS: TWO USED SAMPLES WERE RETURNED. THE DEVICE HISTORY REVIEW SHOWED NO ISSUES WERE FOUND. THERE WERE NO RELATED QUALITY NOTIFICATIONS. BD PAS RECEIVED ONE SAMPLE FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE CUSTOMERS SAMPLE WAS EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE OF ¿STOPPER POPOFF¿ WITH THE INCIDENT LOT WAS NOT OBSERVED AS THE SAMPLE MET THE REQUIRED SPECIFICATIONS. WATER FILL TESTING WAS CONDUCTED ON THE CUSTOMER SAMPLE AND ¿STOPPER POPOFF¿ WAS NOT OBSERVED. ADDITIONALLY, 20 RETENTION SAMPLES WERE SELECTED FROM IN-HOUSE INVENTORY AND INSPECTED FOR ¿STOPPER POPOFF¿ AND NO ISSUES WERE OBSERVED AS ALL RETENTION SAMPLES MET SPECIFICATIONS. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ISSUES WERE IDENTIFIED. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED (B)(4) WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BECAUSE THE DEFECT WAS NOT OBSERVED IN THE SAMPLE AND THE WATER FILL TEST ON THE RETENTION SAMPLES. UDI# (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE STOPPERS WERE POPPING OFF WITH THE 13 X 75 MM X 4.0 ML BD VACUTAINER® PLUS LAVENDER BD HEMOGARD¿ CLOSURE. NO MEDICAL INTERVENTIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523934 13 X 75 MM X 4.0 ML BD VACUTAINER® PLUS LAVENDER BD HEMOGARD¿ CLOSURE COLLECTION TUBE FKA BECTON, DICKINSON & CO. 6253705

    Patients

    Seq Age Sex Outcome Treatment
    1 Other