BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 8006996 · Received October 25, 2018

    Report

    Report Number
    8041187-2018-00377
    Event Type
    Malfunction
    Date Received
    October 25, 2018
    Date of Event
    October 2, 2018
    Report Date
    October 29, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ON 10/08/2018, THE CUSTOMER CONFIRMED THAT THERE WAS NO COMPLAINT FOR LEAKAGE AGAINST THE PREVIOUSLY REPORTED DEVICE AND THE COMPLAINT WAS FOR PHLEBITIS, WHICH IS NOT A REPORTABLE MALFUNCTION. THE COMPLAINT WILL BE CANCELED. NO FURTHER INVESTIGATION ACTIVITIES WILL BE CONDUCTED. IT WAS REPORTED WITH THE USE OF THE BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER THERE WAS AN ISSUE WITH PHLEBITIS. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION. THIS ISSUE IS NOT REPORTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER USING BD VENFLON PRO SAFETY¿ PATIENTS HAD PHLEBITIS. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8051006, MEDICAL DEVICE EXPIRATION DATE: 02/28/2021, DEVICE MANUFACTURE DATE: 04/05/2018. MEDICAL DEVICE LOT #: 6265333, MEDICAL DEVICE EXPIRATION DATE: 09/30/2019, DEVICE MANUFACTURE DATE: 10/20/2016. MEDICAL DEVICE LOT #: 7321433, MEDICAL DEVICE EXPIRATION DATE: 11/30/2020, DEVICE MANUFACTURE DATE: 12/28/2017. MEDICAL DEVICE LOT #: 8110203, MEDICAL DEVICE EXPIRATION DATE: 04/30/2021, DEVICE MANUFACTURE DATE: 05/16/2018. (B)(6). 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

    IT WAS REPORTED THAT BD VENFLON PRO SAFETY¿ LEAKED. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844126 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other