BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOFLON 26GA 0.6MM OD 19MM L

    MDR report key: 12565197 · Received October 1, 2021

    Report

    Report Number
    8041187-2021-00883
    Event Type
    Injury
    Date Received
    October 1, 2021
    Date of Event
    September 1, 2021
    Report Date
    October 6, 2021
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-09-28. H6: INVESTIGATION SUMMARY: ONE PHOTO AND SEVEN REPRESENTATIVE SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. THREE REPRESENTATIVE SAMPLES FROM BATCH 0175673 AND ONE REPRESENTATIVE SAMPLE FROM BATCH 82031N WERE ALSO RECEIVED, THE SAMPLE FROM BATCH 82031N IS NOT A BD PRODUCT AND NO FURTHER INVESTIGATION WAS COMPLETED ON IT. FROM THE PHOTO, A TOPWEB FROM BATCH 0050222 WAS OBSERVED. THE SEVEN REPRESENTATIVE SAMPLES FROM BATCH 0050222 WERE SUBJECTED TO VISUAL INSPECTION AND CATHETER PULL TESTING. BOTH INSPECTION RESULTS PASSED, AND NO ABNORMALITIES WERE OBSERVED. THE THREE REPRESENTATIVE SAMPLES FROM BATCH 0175673 WERE SUBJECTED TO VISUAL INSPECTION AND THE CATHETER PULL TEST. BOTH INSPECTION RESULTS PASSED, AND NO ABNORMALITIES WERE 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. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEOFLON 26GA 0.6MM OD 19MM L CATHETER SEPARATED FROM THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN THE PROCEDURE OF INTRODUCING THE IV CANNULA TO A 14-DAY-OLD INFANT, IT HAPPENED THAT WHEN THE NEEDLE WAS PULLED OUT, THE TEFLON CATHETER DETACHED FROM THE HOLDER AND REMAINED IN THE VEIN. WITH ULTRASOUND THEY SAW THAT THE CATHETER WAS ACTUALLY IN A VESSEL. AS THEY COULD NOT SOLVE THE COMPLICATION ON THEIR OWN, THE PATIENT WAS URGENTLY TRANSFERRED TO THE (B)(6) , WHERE HE WAS TAKEN OVER BY A SURGEON. WE DON'T HAVE MORE INFORMATION YET. AS SOON AS WE RECEIVE THEM, WE WILL LET YOU KNOW. SUMMARY OF ADVERSE EVENT AT THE APPLICATION OF IV CANNULA 26G ON (B)(6) 2021: AT THE HANDOVER OF THE ON-CALL SERVICE (1.9. AT 14.25) AT THE PEDIATRIC WARD AT THE GIRL MR (MI 163268) DUE TO THE NEED FOR TRANSPORT I INTRODUCE IV CANNULA 26G (BD NEOFLON, 0.6X19MM) IN THE RIGHT LEG - PERIPHERAL VEIN SUPERFICIALIS. THE INTRODUCTION SUCCEEDS ON THE FIRST ATTEMPT, THERE IS BLOOD REFLUX. WHEN I PULLED OUT THE NEEDLE, I ALSO HAVE A "BUTTERFLY" IN MY HANDS, WHICH HAS NEVER HAPPENED BEFORE, BECAUSE IN THE CANNULA THE BUTTERFLY AND THE PLASTIC CATHETER MUST BE ONE UNIT - CONNECTED. I ASSUME THAT THE CATHETER HAS REMAINED IN THE VEIN, SO I IMMEDIATELY CALL THE WARD PEDIATRICIAN. DR. DOES AN ULTRASOUND, WHERE THE PLASTIC CATHETER IS ALSO VISIBLE. ULTRASOUND IS ALSO PERFORMED BY DR. (THE HEAD OF THE INTERNAL DEPARTMENT), WHO SAYS THAT THERE WILL BE NO PROBLEMS WITH THIS CATHETER, BUT THAT IT WILL NEED TO BE REMOVED IN A FEW DAYS. DR. ALSO REGISTERS THE EVENT IN THE DISCHARGE FORM FOR TRANSFER TO (B)(6) (DEPARTMENT OF PEDIATRIC SURGERY AND INTENSIVE CARE IN (B)(6)), AND ALSO CALLS THEM BY PHONE. ALL PRESENT AGREE THAT THIS IS AN INDUSTRIAL DEFECT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEOFLON 26GA 0.6MM OD 19MM L CATHETER SEPARATED FROM THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN THE PROCEDURE OF INTRODUCING THE IV CANNULA TO A (B)(6) INFANT, IT HAPPENED THAT WHEN THE NEEDLE WAS PULLED OUT, THE TEFLON CATHETER DETACHED FROM THE HOLDER AND REMAINED IN THE VEIN. WITH ULTRASOUND THEY SAW THAT THE CATHETER WAS ACTUALLY IN A VESSEL. AS THEY COULD NOT SOLVE THE COMPLICATION ON THEIR OWN, THE PATIENT WAS URGENTLY TRANSFERRED TO THE UNIVERSITY CLINICAL CENTER LJUBLJANA, WHERE HE WAS TAKEN OVER BY A SURGEON. WE DON'T HAVE MORE INFORMATION YET. AS SOON AS WE RECEIVE THEM, WE WILL LET YOU KNOW. SUMMARY OF ADVERSE EVENT AT THE APPLICATION OF IV CANNULA 26G ON 1.9.2021: AT THE HANDOVER OF THE ON-CALL SERVICE (1.9. AT 14.25) AT THE PEDIATRIC WARD AT THE GIRL MR (MI 163268) DUE TO THE NEED FOR TRANSPORT I INTRODUCE IV CANNULA 26G (BD NEOFLON, 0.6X19MM) IN THE RIGHT LEG - PERIPHERAL VEIN SUPERFICIALIS. THE INTRODUCTION SUCCEEDS ON THE FIRST ATTEMPT, THERE IS BLOOD REFLUX. WHEN I PULLED OUT THE NEEDLE, I ALSO HAVE A "BUTTERFLY" IN MY HANDS, WHICH HAS NEVER HAPPENED BEFORE, BECAUSE IN THE CANNULA THE BUTTERFLY AND THE PLASTIC CATHETER MUST BE ONE UNIT - CONNECTED. I ASSUME THAT THE CATHETER HAS REMAINED IN THE VEIN, SO I IMMEDIATELY CALL THE WARD PEDIATRICIAN. DR. DOES AN ULTRASOUND, WHERE THE PLASTIC CATHETER IS ALSO VISIBLE. ULTRASOUND IS ALSO PERFORMED BY DR. (THE HEAD OF THE INTERNAL DEPARTMENT), WHO SAYS THAT THERE WILL BE NO PROBLEMS WITH THIS CATHETER, BUT THAT IT WILL NEED TO BE REMOVED IN A FEW DAYS. DR. ALSO REGISTERS THE EVENT IN THE DISCHARGE FORM FOR TRANSFER TO KOOKIT (DEPARTMENT OF PEDIATRIC SURGERY AND INTENSIVE CARE IN UMC LJ), AND ALSO CALLS THEM BY PHONE. ALL PRESENT AGREE THAT THIS IS AN INDUSTRIAL DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1461793 NEOFLON 26GA 0.6MM OD 19MM L CATHETER FOZ 0050222

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention