BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    13X100 MM 5.0 ML BD VACUTAINER® PLUS PLASTIC SST TUBE GOLD BD HEMOGARD¿ CLOSURE

    MDR report key: 6834808 · Received August 31, 2017

    Report

    Report Number
    1024879-2017-00130
    Event Type
    Malfunction
    Date Received
    August 31, 2017
    Date of Event
    August 10, 2017
    Report Date
    November 28, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    PMA / PMN Number
    K901449
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). INVESTIGATION: THREE PHOTOS WERE PROVIDED BY THE CUSTOMER SHOWING THE POP-OFF OF THE TUBE CLOSURE AND BLOOD SPLATTER. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH 7061934 REORDER NUMBER (B)(4). PRODUCT WAS MANUFACTURED AT THE BD (B)(4) SITE MARCH, 2017. PRODUCT QUALITY IS EVALUATED DURING THE MANUFACTURING PROCESS WITH PRESCRIBED VARIABLE AND ATTRIBUTES INSPECTIONS. ALL INSPECTIONS WERE IN COMPLIANCE WITH REQUIREMENTS. THIS COMPLAINT IS CONFIRMED BASED ON THE EVALUATION OF THE FAILURE MODE DESCRIBED BY THE CUSTOMER. CAPA (B)(4) HAS BEEN INITIATED FOR DOCUMENTATION RELATED TO THIS ISSUE TO DOCUMENT THE INVESTIGATION PATH, ROOT CAUSE ANALYSIS AND REMEDIATION PLAN TO INCLUDE CORRECTIVE AND PREVENTIVE ACTIONS. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR STOPPER POP-OFF WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, EVALUATION OF THE CUSTOMER SAMPLES ACKNOWLEDGES THE ISSUE OF STOPPER POP-OFF. 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 IS AWARE OF THIS PRODUCT ISSUE AND FURTHER INVESTIGATION HAS BEEN INITIATED THROUGH A CAPA. BASED ON EVALUATION OF THE CUSTOMER PHOTOS AND SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR STOPPER POP-OFF WITH THE INCIDENT LOT WAS OBSERVED. CAPA 126212 HAS BEEN INITIATED TO DOCUMENT THE INVESTIGATION AND ROOT CAUSE ANALYSIS OF THE REPORTED INCIDENTS. THE CAPA INVESTIGATION IS CURRENTLY ON-GOING AND WILL BE UPDATED AS POTENTIAL ROOT CAUSE(S) ARE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAP OF THE 5.0 ML BD VACUTAINER® PLUS PLASTIC SST TUBE POPPED OFF CAUSING BLOOD TO SPLATTER ONTO THE FLOOR AS WELL AS ON THE HEALTHCARE WORKERS SKIN, GLOVES AND GOWN. THERE WAS NO REPORT OF MUCOUS MEMBRANE EXPOSURE, INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616323 13X100 MM 5.0 ML BD VACUTAINER® PLUS PLASTIC SST TUBE GOLD BD HEMOGARD¿ CLOSURE BLOOD COLLECTION TUBE JKA BECTON, DICKINSON & CO., (BD) 7061934

    Patients

    Seq Age Sex Outcome Treatment
    1 Other