BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER

    MDR report key: 9218059 · Received October 22, 2019

    Report

    Report Number
    8041187-2019-00839
    Event Type
    Malfunction
    Date Received
    October 22, 2019
    Date of Event
    October 8, 2019
    Report Date
    December 27, 2019
    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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: 5 UNOPENED AND 6 OPENED SAMPLES WERE RETURNED FOR INVESTIGATION. THE RETURNED SAMPLES WERE SUBJECTED TO VISUAL INSPECTION, END CAP WITH FLOW CONTROL PLUG DISASSEMBLY FORCE, END CAP DIMENSION 6.9 MEASUREMENT AND FLOW CONTROL PLUG DIMENSION B MEASUREMENT. THE RETURNED SAMPLES PASSED THE ACCEPTANCE CRITERIA. NO ABNORMALITY WAS OBSERVED. UNABLE TO CONFIRM THE CUSTOMER EXPERIENCE BASED ON SAMPLES RETURNED. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. A REVIEW OF 12 MONTHS QN ON REPORTED NONCONFORMANCE WAS PERFORMED. NO RELATED QN WAS RAISED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER THERE IS AN ISSUE WITH REMOVING LUER LOCK PLUG. IT IS DIFFICULT TO LOOSEN/REMOVE THE PLUG AND IT PULLS OFF FLASHBACK CHAMBER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ARE HAVING PROBLEMS WITH THE RECENT BATCHES OF CANNULA WE HAVE BEEN USING. WHEN TRYING TO REMOVE LUER LOCK PLUG PRIOR TO, AND DURING, CANNULATION WE ARE FINDING IT DIFFICULT TO LOOSEN/REMOVE THE PLUG AND IT PULLS OFF FLASHBACK CHAMBER WITH IT RESULTING IN BLOOD SPILLAGE. WE USE BD VENFLONS EVERY DAY AND ARE FINDING IT IS IMPACTING ON OUR WORK LISTS. REPORTED FEELS MATERIAL AND COLOR ON THESE BATCHES ARE DIFFERENT FROM ALL PREVIOUSLY USED.

    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 #: 9164765. MEDICAL DEVICE EXPIRATION DATE: 2022-05-31. DEVICE MANUFACTURE DATE: 2019-06-13. MEDICAL DEVICE LOT #: 9162664. MEDICAL DEVICE EXPIRATION DATE: 2022-05-31. DEVICE MANUFACTURE DATE: 2019-06-14. MEDICAL DEVICE LOT #: 9162846. MEDICAL DEVICE EXPIRATION DATE: 2022-05-31. DEVICE MANUFACTURE DATE: 2019-06-11. MEDICAL DEVICE LOT #: 9162634. MEDICAL DEVICE EXPIRATION DATE: 2022-05-31. DEVICE MANUFACTURE DATE: 2019-06-12. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER THERE IS AN ISSUE WITH REMOVING LUER LOCK PLUG. IT IS DIFFICULT TO LOOSEN/REMOVE THE PLUG AND IT PULLS OFF FLASHBACK CHAMBER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ARE HAVING PROBLEMS WITH THE RECENT BATCHES OF CANNULA WE HAVE BEEN USING. WHEN TRYING TO REMOVE LUER LOCK PLUG PRIOR TO, AND DURING, CANNULATION WE ARE FINDING IT DIFFICULT TO LOOSEN/REMOVE THE PLUG AND IT PULLS OFF FLASHBACK CHAMBER WITH IT RESULTING IN BLOOD SPILLAGE. WE USE BD VENFLONS EVERY DAY AND ARE FINDING IT IS IMPACTING ON OUR WORK LISTS. REPORTED FEELS MATERIAL AND COLOR ON THESE BATCHES ARE DIFFERENT FROM ALL PREVIOUSLY USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015579 BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other