BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER

    MDR report key: 9539735 · Received January 2, 2020

    Report

    Report Number
    8041187-2019-01058
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Date of Event
    December 18, 2019
    Report Date
    January 14, 2020
    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
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. 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. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CAPS ON THE BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETERS WERE DIFFICULT TO REMOVE AND "TOO RIGID", RESULTING IN THE CANNULA CHAMBER REMAINING IN THE PATIENT AND FILLING WITH BLOOD AFTER FLASHING DURING USE. LOT #'S 8082340 AND 9162995 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: "THE CUSTOMER REPORTED THAT HE NOTICED THAT SOMETHING HAS CHANGED IN THESE VENFLONS. THE WHITE CAPS ARE DIFFICULT TO REMOVE FROM THE BACK OF THE VENFLON AND THE SEALING OF THE VENFLON WITH THE WHITE CAP IS ALSO TOO RIGID. THE RESULT IS THAT THE CHAMBER OF THE CANNULA THAT REMAINS IN THE PATIENT IS FILLED WITH BLOOD AFTER FLASHING. ACCORDING TO THE CUSTOMER THIS IS NOT ALLOWED. THIS IS A SIGN THAT THEY ARE NOT CLOSED."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8082340. MEDICAL DEVICE EXPIRATION DATE: 2021-03-31. DEVICE MANUFACTURE DATE: 2018-05-02. MEDICAL DEVICE LOT #: 9162995. MEDICAL DEVICE EXPIRATION DATE: 2022-05-31. DEVICE MANUFACTURE DATE: 2019-06-11. 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 CAPS ON THE BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETERS WERE DIFFICULT TO REMOVE AND "TOO RIGID", RESULTING IN THE CANNULA CHAMBER REMAINING IN THE PATIENT AND FILLING WITH BLOOD AFTER FLASHING DURING USE. LOT #'S 8082340 AND 9162995 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE CUSTOMER REPORTED THAT HE NOTICED THAT SOMETHING HAS CHANGED IN THESE VENFLONS. THE WHITE CAPS ARE DIFFICULT TO REMOVE FROM THE BACK OF THE VENFLON AND THE SEALING OF THE VENFLON WITH THE WHITE CAP IS ALSO TOO RIGID. THE RESULT IS THAT THE CHAMBER OF THE CANNULA THAT REMAINS IN THE PATIENT IS FILLED WITH BLOOD AFTER FLASHING. ACCORDING TO THE CUSTOMER THIS IS NOT ALLOWED. THIS IS A SIGN THAT THEY ARE NOT CLOSED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4766 BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other