BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® NO ADDITIVE (Z) PLUS TUBES

    MDR report key: 8800751 · Received July 17, 2019

    Report

    Report Number
    1024879-2019-01214
    Event Type
    Malfunction
    Date Received
    July 17, 2019
    Date of Event
    June 28, 2019
    Report Date
    August 5, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES AND PHOTOS WERE EVALUATED AND STOPPER POP OFF CAN BE OBSERVED; HOWEVER, THE STOPPERS DO NOT APPEAR TO HAVE BEEN MANUFACTURED BY BD. 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. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODE FOR STOPPER POP OFF WITH THE INCIDENT LOT WAS NOT OBSERVED. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT: SEE SECTION H.10.

    Description of Event or Problem · 0

    MATERIAL NO. 366408, BATCH NO. 9042930. IT WAS REPORTED THAT AFTER USE OF THE BD VACUTAINER® NO ADDITIVE (Z) PLUS TUBES THE STOPPER WAS CREEPING OUT AS WELL AS STICKING TO MACHINE DURING TESTING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE REPLACEMENT TUBE CAP POPPING OFF AFTER SOME TIME. THIS ISSUE HAS BEEN OBSERVED IN THE PAST BUT WENT AWAY AND THEN NOW HAS COME BACK. SEVERAL INCIDENTS HAVE OCCURRED. AFTER TUBE GOES THROUGH TESTING IT GETS CAPPED WITH A DIFFERENT BLUE CAP. THIS BLUE CAP SLOWLY POPS OFF WHILE SITTING ON THE RACK OR WHILE IN THE FRIDGE WHERE IT IS STORED."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO. 366408, BATCH NO. 9042930. IT WAS REPORTED THAT AFTER USE OF THE BD VACUTAINER® NO ADDITIVE (Z) PLUS TUBES THE STOPPER WAS CREEPING OUT AS WELL AS STICKING TO MACHINE DURING TESTING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE REPLACEMENT TUBE CAP POPPING OFF AFTER SOME TIME. THIS ISSUE HAS BEEN OBSERVED IN THE PAST BUT WENT AWAY AND THEN NOW HAS COME BACK. SEVERAL INCIDENTS HAVE OCCURRED. AFTER TUBE GOES THROUGH TESTING IT GETS CAPPED WITH A DIFFERENT BLUE CAP. THIS BLUE CAP SLOWLY POPS OFF WHILE SITTING ON THE RACK OR WHILE IN THE FRIDGE WHERE IT IS STORED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594378 BD VACUTAINER® NO ADDITIVE (Z) PLUS TUBES SPECIMEN TRANSPORT AND STORAGE CONTAINER FMH BECTON, DICKINSON & CO., (BD) 9042930

    Patients

    Seq Age Sex Outcome Treatment
    1 Other