BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD NEOFLON¿ IV CANNULA SYSTEM 24 G X 1 IN.

    MDR report key: 6551341 · Received May 8, 2017

    Report

    Report Number
    8041187-2017-00041
    Event Type
    Injury
    Date Received
    May 8, 2017
    Date of Event
    April 13, 2017
    Report Date
    May 30, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    K850276
    Removal / Correction Number
    81917
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: TWO USED AND 48 UNUSED SAMPLES WERE RETURNED FOR EVALUATION. A VISUAL INSPECTION OF THE USED SAMPLES REVEALED CATHETER PEELBACK. TEN OF THE 48 UNUSED SAMPLES WERE TESTED FOR BEVEL ANGLE AND TIP OUTSIDE DIAMETER MEASUREMENTS. THE SAMPLES MET THE BEVEL ANGEL AND TIP OD SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6230410. A MANUFACTURING REVIEW OBSERVED NO ABNORMALITIES THAT COULD HAVE INFLUENCED THE REPORTED ISSUE. CONCLUSION: THE ROOT CAUSE FOR THIS INCIDENT WAS DETERMINED TO BE MATERIAL USED TO MANUFACTURE THE DEVICE. REMEDIAL ACTION REQUIRED: CAPA (B)(4) HAS BEEN INITIATED TO REVIEW THE IV CATHETER TUBING MATERIAL.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER OF A BD NEOFLON¿ IV CANNULA SYSTEM 24 G X 1 IN. BENT AND TWISTED WHILE BEING INSERTED. THERE WAS NO HARM TO THE PATIENT BUT THE INCIDENT RESULTED IN A NEEDLE STICK TO THE MEDICAL PROFESSIONAL. IT WAS ALSO REPORTED THAT NO MEDICAL INTERVENTION WAS NECESSARY/PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332732 BD NEOFLON¿ IV CANNULA SYSTEM 24 G X 1 IN. INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 6230410

    Patients

    Seq Age Sex Outcome Treatment
    1 Other