BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEOFLON¿ IV CANNULA

    MDR report key: 8791218 · Received July 15, 2019

    Report

    Report Number
    8041187-2019-00540
    Event Type
    Malfunction
    Date Received
    July 15, 2019
    Date of Event
    June 26, 2019
    Report Date
    August 30, 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
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 7 PHOTOS AND 3 USED SAMPLES WERE RECEIVED FOR INVESTIGATION. 7 PHOTOS WERE RETURNED FOR INVESTIGATION. THE 1ST AND 2ND PHOTOS SHOW PEELBACK ON CATHETER TIP. NO ABNORMALITY OBSERVED ON THE 3RD AND 4TH PHOTO RETURNED, SIGN OF USAGE (BLOOD STAIN) WAS OBSERVED FROM THE 5TH AND 6TH PHOTO. THE 7TH PHOTO SHOWS THE 4PCS SAMPLES WITH BATCH #7165125-1PCS AND #8020474-3PCS. THE USED SAMPLES WERE SUBJECTED TO VISUAL INSPECTION. PEELBACK WAS OBSERVED ON THE USED SAMPLES. THE PROBABLE ROOT CAUSE FOR PEELBACK COULD BE DUE TO TUBING MATERIAL. CAPA#81917 WAS ISSUED TO REVIEW THE TUBING MATERIAL. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD NEOFLON¿ IV CANNULAS' TIPS PEELED BACK DURING THE PUNCTURE, RENDERING THEM DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "WHEN PUNCTURING, THE CATHETER BECAME DEFECT. THE ISSUE OCCURRED 4 TIMES."

    Additional Manufacturer Narrative · 1

    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 3 BD NEOFLON¿ IV CANNULAS' TIPS PEELED BACK DURING THE PUNCTURE, RENDERING THEM DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "WHEN PUNCTURING, THE CATHETER BECAME DEFECT. THE ISSUE OCCURRED 4 TIMES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582651 BD NEOFLON¿ IV CANNULA INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 8020474

    Patients

    Seq Age Sex Outcome Treatment
    1 Other