BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PREVENTIS 1/2IN HYPAK SAFETY DEVICE

    MDR report key: 8356113 · Received February 20, 2019

    Report

    Report Number
    3001741852-2019-00002
    Event Type
    Malfunction
    Date Received
    February 20, 2019
    Date of Event
    January 30, 2019
    Report Date
    March 4, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED BECAUSE THE SAMPLES HAVE NOT BEEN RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY MANUFACTURING OR MATERIAL DEFECTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED FAILURE. THUS, THE COMPLAINT COULD NOT BE VERIFIED AND A ROOT CAUSE COULD NOT BE DETERMINED WITH CONFIDENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SAFETY DEVICE ON A BD PREVENTIS 1/2IN HYPAK SAFETY DEVICE COULD NOT BE ACTIVATED. THIS OCCURRED ON 10 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7203359, MEDICAL DEVICE EXPIRATION DATE: 2021-06-30, DEVICE MANUFACTURE DATE: 2017-07-22. MEDICAL DEVICE LOT #: 7233228, MEDICAL DEVICE EXPIRATION DATE: 2021-07-31, DEVICE MANUFACTURE DATE: 2017-08-21. MEDICAL DEVICE LOT #: 7243187 MEDICAL DEVICE EXPIRATION DATE: 2021-08-31 DEVICE MANUFACTURE DATE: 2017-08-31 MEDICAL DEVICE LOT #: 7245203, MEDICAL DEVICE EXPIRATION DATE: 2021-08-31, DEVICE MANUFACTURE DATE: 2017-09-02. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAFETY DEVICE ON A BD PREVENTS 1/2IN HYPAK SAFETY DEVICE COULD NOT BE ACTIVATED. THIS OCCURRED ON 10 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149357 BD PREVENTIS 1/2IN HYPAK SAFETY DEVICE NEEDLE SHIELD SYSTEM FMI BECTON DICKINSON SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other