BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON ¿ PRO SAFETY IV CATHETER

    MDR report key: 7740642 · Received August 1, 2018

    Report

    Report Number
    8041187-2018-00260
    Event Type
    Malfunction
    Date Received
    August 1, 2018
    Date of Event
    July 4, 2018
    Report Date
    September 5, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: YES.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE ACTUAL SAMPLE WAS RETURNED FOR INVESTIGATION OF THIS COMPLAINT. THE CANNULA HUB WAS NOT RETURNED. THE CANNULA WAS EXPOSED AND SAFETY MECHANISM HAS NOT BEEN ACTIVATED. DHR REVIEW SHOWED NO SIMILAR COMPLAINT WAS RECEIVED FOR BATCH # 7142154. NO QUALITY NOTIFICATIONS WERE RAISED FOR THE BATCH AND NO ABNORMALITIES OBSERVED AFTER REVIEWING PREVENTIVE, MAINTENANCE AND CALIBRATION EQUIPMENT. THE ACTUAL SAMPLE WAS SUBJECTED TO VISUAL INSPECTION, MANUAL ACTIVATION OF SAFETY FUNCTION AND NEEDLE CAP DIMENSION MEASUREMENT. THE SAMPLE PASSED THE ACCEPTANCE CRITERIA. THE SAFETY MECHANISM WAS MANUALLY ACTIVATED AND THE CANNULA WAS ABLE TO BE SECURED IN THE SAFETY MECHANISM. THE SAMPLE PASSED THE ACCEPTANCE CRITERIA. THE UNINTENTIONAL SEPARATION WHICH RESULTED IN THE EXPOSED CANNULA COULD BE DUE TO PRODUCT APPLICATION OR DAMAGE ON THE CANNULA HUB. THE NON-CONFORMANCE OF THIS COMPLAINT CANNOT BE DETERMINED AS THE ACTUAL CANNULA HUB WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PATIENT'S CANNULATION BEFORE SURGERY, THE NEEDLE OF A BD VENFLON PRO SAFETY IV CATHETER SAFETY SYSTEM FAILED TO RETRACT. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PATIENT'S CANNULATION BEFORE SURGERY, THE NEEDLE OF A BD VENFLON¿ PRO SAFETY IV CATHETER SAFETY SYSTEM FAILED TO RETRACT. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE#: (B)(6). 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 DURING THE PATIENT'S CANNULATION BEFORE SURGERY, THE NEEDLE OF A BD VENFLON¿ PRO SAFETY IV CATHETER SAFETY SYSTEM FAILED TO RETRACT. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579924 BD VENFLON ¿ PRO SAFETY IV CATHETER IV CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 7142154

    Patients

    Seq Age Sex Outcome Treatment
    1 Other