BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER

    MDR report key: 12862765 · Received November 23, 2021

    Report

    Report Number
    8041187-2021-00997
    Event Type
    Malfunction
    Date Received
    November 23, 2021
    Date of Event
    October 27, 2021
    Report Date
    December 2, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL?: YES. D9: RETURNED TO MANUFACTURER ON: 11/22/2021. H6: INVESTIGATION: THREE PHOTOS AND TEN SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. THE PHOTOS SHOW A SHELF CARTON LABEL OF BATCH 1202076, A 20G UNIT PACKAGE WITH OPENING TAB, AND FOUR PIECES OF 20G UNIT PACKAGING WITH DEFORMED PACKAGING. THE REPRESENTATIVE SAMPLE OF BATCH 1202076 WAS SUBJECTED TO VISUAL INSPECTION, THE SAMPLE PASSED THE ACCEPTANCE CRITERIA WITH NO ABNORMALITIES OBSERVED. THE NINE ACTUAL SAMPLES WERE SUBJECTED TO VISUAL INSPECTION. ALL NINE SAMPLES WERE OBSERVED WITH DEFORMED PACKAGING. THREE OF THE NINE SAMPLES WERE OBSERVED WITH THE BOTTOM WEB OF THE UNIT PACKAGE SHRUNK AND DEFORMED NEAR THE END CAP AREA OF THE VPS PART CAUSING IT TO FORCE OPEN AT THE OPENING TAB. ONE OF THE DEFECTED SAMPLES WAS SUBJECTED TO FURTHER VISUAL INSPECTION OF THE SEALING FEATURES. GRID MARK WAS OBSERVED ON THE BOTTOM WEB, SHOWING THAT THE SEALING PROCESS HAS BEEN COMPLETED AND THE SEAL WIDTH PASSED THE INSPECTION CRITERIA. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. THE MANUFACTURING PROCESS WAS REVIEWED. THERE IS NO PROCESS IN THE MANUFACTURING THAT WOULD CAUSE THE REPORTED DEFECT. THERE WAS ALSO NO ABNORMALITY DURING THE PRODUCTION OF THE REPORTED BATCH. THEREFORE, THE REPORTED DEFECT COULD HAVE OCCURRED OUTSIDE OF THE MANUFACTURING FACILITY. IN ADDITION, A GRID MARK WAS OBSERVED ON THE BOTTOM WEB. THIS SHOWS THAT THE SEALING PROCESS WAS COMPLETED, AND THE SEAL WIDTH IS WITHIN SPECIFICATION. THE PROBABLE ROOT CAUSE FOR THE PACKAGE DEFORMATION COULD BE DUE TO THE PRODUCT BEING EXPOSED TO HEAT DURING HANDLING (TRANSPORTATION, STORAGE, LOADING, AND UNLOADING).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER PACKAGING WAS DAMAGED/WARPED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BOXES OF VENFLON PRO SAFETY KANNULAS WHOSE PACKAGES ARE COMPLETELY CURLED AND WARPED. AS A RESULT OF HEAT OR SOMETHING ELSE, SOME OF THE PACKAGES HAD OPENED AT THEIR ENDS. THE PLASTICS IN THE PACKAGING SEEM TO HAVE BEEN TOO HOT AT SOME POINT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER PACKAGING WAS DAMAGED/WARPED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BOXES OF VENFLON PRO SAFETY KANNULAS WHOSE PACKAGES ARE COMPLETELY CURLED AND WARPED. AS A RESULT OF HEAT OR SOMETHING ELSE, SOME OF THE PACKAGES HAD OPENED AT THEIR ENDS. THE PLASTICS IN THE PACKAGING SEEM TO HAVE BEEN TOO HOT AT SOME POINT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1757862 BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 1202076

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown