BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PRO SAFETY IV CATHETER

    MDR report key: 13451740 · Received February 4, 2022

    Report

    Report Number
    8041187-2022-00065
    Event Type
    Malfunction
    Date Received
    February 4, 2022
    Date of Event
    January 21, 2022
    Report Date
    February 23, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO CORRECTED INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT BD VENFLON¿ PRO SAFETY IV CATHETER HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿A MEDICAL ASSISTANT FROM THE OUTPATIENT CLINIC NOTICED THAT WHEN CONDUCTING PUNCTURE WITH YOUR CANNULAS (VENFLON PRO SAFETY) SOMETHING DETACHES FROM THE PLASTIC CANNULA. " H.6. IMDRF ANNEX A GRID: A180104 - DEVICE CONTAMINATION WITH CHEMICAL OR OTHER MATERIAL THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 2/15/2022. H.6. INVESTIGATION: FOUR PHOTOS, THIRTY-TWO REPRESENTATIVE SAMPLES, AND ONE USED SAMPLE IN A PLASTIC BAG WAS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. PHOTOS 1 AND 2 SHOW A SAMPLE WITH FOREIGN MATTER ON THE CATHETER, BUT THE DEFECT COULD NOT BE SEEN CLEARLY. PHOTO 3 AND PHOTO 4 SHOW A SHELF CARTON LABEL WITH BATCH 1231151 AND A TOP WEB WITH BATCH 1231151, RESPECTIVELY. ALL RETURNED SAMPLES WERE SUBJECTED TO VISUAL INSPECTION. ALL SAMPLES PASSED THE ACCEPTANCE CRITERIA, AND NO ABNORMALITY WAS OBSERVED. 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 BD VENFLON¿ PRO SAFETY IV CATHETER WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿A MEDICAL ASSISTANT FROM THE OUTPATIENT CLINIC NOTICED THAT WHEN CONDUCTING PUNCTURE WITH YOUR CANNULAS (VENFLON PRO SAFETY) SOMETHING DETACHES FROM THE PLASTIC CANNULA. "

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VENFLON¿ PRO SAFETY IV CATHETER HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿A MEDICAL ASSISTANT FROM THE OUTPATIENT CLINIC NOTICED THAT WHEN CONDUCTING PUNCTURE WITH YOUR CANNULAS (VENFLON PRO SAFETY) SOMETHING DETACHES FROM THE PLASTIC CANNULA. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1314588 BD VENFLON¿ PRO SAFETY IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 1231151

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown