BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER

    MDR report key: 14428048 · Received May 18, 2022

    Report

    Report Number
    8041187-2022-00253
    Event Type
    Malfunction
    Date Received
    May 18, 2022
    Date of Event
    April 25, 2022
    Report Date
    May 19, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 05-MAY-2022. H.6. INVESTIGATION: ONE ACTUAL SAMPLE OF BATCH 1203323 WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. THE RETURNED SAMPLE WAS SUBJECTED TO VISUAL INSPECTION AND PENETRATION TESTING. FROM THE SAMPLE, THE TEAM OBSERVED THAT THE BOTTOM WEB OF THE UNIT PACKAGE HAD SHRUNK AND BECOME DEFORMED NEAR THE END CAP AREA OF THE VENFLON PRO SAFETY PART CAUSING IT TO BE FORCED OPEN AT THE OPENING TAB. THE RETURNED SAMPLE PASSED THE PENETRATION TESTING, AND NO BLUNT NEEDLE WAS OBSERVED. FURTHER VISUAL INSPECTION OF THE SEALING FEATURES WAS PERFORMED, AND A GRID MARK WAS OBSERVED ON THE BOTTOM WEB. THIS SHOWS THAT THE SEALING PROCESS WAS 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 PART OF THE MANUFACTURING PROCESS THAT WOULD CAUSE THE REPORTED DEFECT. BASED ON THE DEFECT SIMULATION PERFORMED ON SIMILAR PACKAGING MATERIALS, THE PRODUCT COULD HAVE BEEN SUBJECTED TO A TEMPERATURE UP TO 80 DEGREES CELSIUS. THERE IS NO PROCESS DURING MANUFACTURING THAT COULD CAUSE THE PRODUCT TO BE EXPOSED TO SUCH TEMPERATURES. THE PROBABLE ROOT CAUSE FOR THE DEFORMED PACKAGE COULD BE DUE TO THE PRODUCT BEING EXPOSED TO HEAT DURING HANDLING (CARGO TRANSPORTATION, STORAGE, LOADING AND UNLOADING, ETC).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VENILON¿ PRO SAFETY SHIELDED IV CATHETER PACKAGING UNIT WAS DAMAGED, EXPOSING THE PRODUCT AND COMPROMISING ITS STERILITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTED THAT SOME VENILON PRO SAFETY G22 PRODUCTS WERE SUPPLIED TO THEM WITH DISTORTED PACKAGING (THE INNER PACKAGE IMMEDIATE TO THE PRODUCT IS EXPOSED); THE PACKAGE IS RUGGED AS COMPARED TO THE NORMAL SMOOTH CURVATURE OF THE SAME PRODUCT".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER PACKAGING UNIT WAS DAMAGED, EXPOSING THE PRODUCT AND COMPROMISING ITS STERILITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTED THAT SOME VENFLON PRO SAFETY G22 PRODUCTS WERE SUPPLIED TO THEM WITH DISTORTED PACKAGING (THE INNER PACKAGE IMMEDIATE TO THE PRODUCT IS EXPOSED); THE PACKAGE IS RUGGED AS COMPARED TO THE NORMAL SMOOTH CURVATURE OF THE SAME PRODUCT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1803313 BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 1203323

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown