BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER

    MDR report key: 9077683 · Received September 17, 2019

    Report

    Report Number
    8041187-2019-00732
    Event Type
    Malfunction
    Date Received
    September 17, 2019
    Date of Event
    September 2, 2019
    Report Date
    November 20, 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
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: 2 PHOTOS WERE RETURNED FOR INVESTIGATION. THE 1ST AND 2ND PHOTOS SHOW THE LEAKAGE IN BETWEEN THE NEEDLE HUB AND FLOW CONTROL PLUG WAS OBSERVED. THE 1ST PHOTO ALSO SHOWS THE TOP WEB WITH BATCH #9140613. 1 USED SAMPLE WAS RETURNED FOR INVESTIGATION. THE USED SAMPLE HAS BEEN ACTIVATED AND BLOOD WAS OBSERVED ON THE EXTERIOR SURFACE. AS THE SAMPLE WAS CONTAMINATED, THE SAMPLE WAS DECONTAMINATED BEFORE INVESTIGATION. ABLE TO CONFIRM THE CUSTOMER EXPERIENCE BASED ON RETURNED PHOTOS AND RETURNED USED SAMPLE. THE USED SAMPLE WAS SUBJECTED TO VISUAL INSPECTION, THE NEEDLE HUB WAS SUBJECTED TO LUER CONE MEASUREMENT AND THE FCP (FLOW CONTROL PLUG) WAS SUBJECTED TO DIM C MEASUREMENT. THE USED SAMPLE PASSED THE VISUAL INSPECTION AND ACCEPTANCE CRITERIA FOR LUER CONE MEASUREMENT (NEEDLE HUB) AND DIM C MEASUREMENT (FCP). NO ABNORMALITY WAS OBSERVED. CONCLUSION: THE PROBABLE ROOT CAUSE COULD BE DUE TO FCP ASSEMBLY STATION ALIGNMENT OUT WHICH RESULT IN LOW REMOVAL FORCE. HOWEVER, AS THE SAMPLE HAS BEEN DISASSEMBLED FOR DECONTAMINATION, END CAP AND FCP REMOVAL FORCE CANNOT BE TESTED. THE ROOT CAUSE CANNOT BE DETERMINED. PRODUCT APPLICATION: THE OTHER PROBABLE CAUSE WOULD BE DURING PRODUCT APPLICATION. THE USER COULD HAVE HELD THE INCORRECT POSITION DURING WITHDRAWAL AND UNINTENTIONALLY WITHDRAWN THE NEEDLE BY GRIPPING THE FCP INSTEAD OF THE NEEDLE HUB. THIS WOULD LOOSEN THE FCP AND CAUSE THE LEAKAGE TO HAPPEN. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AGAIN A COMPLAINT FROM ARTICLE VENFLON PRO SAFETY 22GA. AFTER PUNCTURING AND WITHDRAWING THE NEEDLE, A LEAK OF BLOOD, A DROP, OCCURRED AT THE CONNECTION WITH THE "END PIECE".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AGAIN A COMPLAINT FROM ARTICLE VENFLON PRO SAFETY 22GA. AFTER PUNCTURING AND WITHDRAWING THE NEEDLE, A LEAK OF BLOOD, A DROP, OCCURRED AT THE CONNECTION WITH THE "END PIECE". THIS IS ALREADY THE 3RD TIME THIS MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872736 BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other