BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PRO SAFETY NEEDLE PROTECTED IV CANNULA

    MDR report key: 16671249 · Received April 3, 2023

    Report

    Report Number
    8041187-2023-00143
    Event Type
    Malfunction
    Date Received
    April 3, 2023
    Date of Event
    February 17, 2023
    Report Date
    April 17, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 2203271. D4. MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2025. H4. DEVICE MANUFACTURE DATE: 12-AUG-2022. D4. MEDICAL DEVICE LOT #: 2203270. D4. MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2025. H4. DEVICE MANUFACTURE DATE: 12-AUG-2022.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 31-MAR-2023 . OUR QUALITY ENGINEER INSPECTED THE 6 SAMPLES, 3 FOR EACH LOT NUMBER, 2203271 AND 2203270 SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF NEEDLE RETRACTION FAILURE WAS CONFIRMED UPON INSPECTION AND TESTING OF THE SAMPLES. DURING FUNCTIONAL TESTING ALL SAMPLES PASSED THE MANUAL ACTIVATION TESTING. HOWEVER, UPON FURTHER REVIEW OF THE SAMPLES IT WAS NOTICED THAT THE SAMPLES ALL HAD A DEFECTIVE COMPONENT WITHIN THE NEEDLE CAP. WITH THE DEFECTIVE COMPONENT THE NEEDLE CAP WOULD HAVE DIFFICULTY TO DETACH FROM THE CANNULA HUB. BD DETERMINED THAT THE CAUSE OF THE FAILURE WAS ASSOCIATED TO THE MANUFACTURING PROCESS THAT PLACES THE DEFECTIVE COMPONENT INTO THE ASSEMBLY. IT IS BELIEVED THAT DURING THAT PROCESS THE COMPONENT WAS MISALIGNED IN THE MANUFACTURING MACHINERY AND WAS DAMAGED WHEN PLACED INTO THE ASSEMBLY. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD VENFLON¿ PRO SAFETY NEEDLE PROTECTED IV CANNULA SAFETY MECHANISM FAILED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: END USERS REPORTING THAT 20G VENFLON PRO SAFETY SAFETY MECHANISM 'JAMS' WHEN HCP ATTEMPTS TO PULL BACK THE NEEDLE AFTER INSERTING THE CANNULA INTO THE VEIN

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD VENFLON¿ PRO SAFETY NEEDLE PROTECTED IV CANNULA SAFETY MECHANISM FAILED.THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER:END USERS REPORTING THAT 20G VENFLON PRO SAFETY SAFETY MECHANISM 'JAMS' WHEN HCP ATTEMPTS TO PULL BACK THE NEEDLE AFTER INSERTING THE CANNULA INTO THE VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580064 BD VENFLON¿ PRO SAFETY NEEDLE PROTECTED IV CANNULA INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown