BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA II¿ IV CATHETER 24G X 0.75 IN.

    MDR report key: 6765853 · Received August 3, 2017

    Report

    Report Number
    3006948883-2017-00027
    Event Type
    Malfunction
    Date Received
    August 3, 2017
    Date of Event
    July 10, 2017
    Report Date
    September 8, 2017
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    K143610
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: REPRESENTATIVE SAMPLES WERE RETURNED FOR EVALUATION. THE WHITE POWDER ON THE CANNULA DISSOLVED IN HCFC (SILICONE OIL AND HCFC COMPATIBLE) WHICH DETERMINE THE FOREIGN BODY ON THE CANNULA TUBE LUBRICATION AND DRYING PROCESS USED IN THE LUBRICATING FLUID 1502C PRECIPITATES, LUBRICATING SILICONE OIL COMPOSITION. INTIMA II PRODUCTS USE THE 1502C LUBRICANT BECAUSE IT CAN FORM A DENSE LAYER ON THE SURFACE OF THE CANNULA TO REDUCE THE PAIN DURING INSERTION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 7110455, 7048200, 7048203. CONCLUSION: THE TEST RESULTS SHOW THE SILICONE OIL FOR THE MEDICAL DEVICE PRODUCTS ARE IN LINE WITH RELEVANT ISO AND FDA STANDARDS.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE AND FAX #: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. UDI# (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS WHITE FOREIGN MATTER ON THE NEEDLE OF BD INTIMA II¿ IV CATHETER 24G X 0.75 IN BEFORE USE. NO MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543107 BD INTIMA II¿ IV CATHETER 24G X 0.75 IN. INTERVASCULAR CATHETER FOZ BD (SUZHOU) 7110455

    Patients

    Seq Age Sex Outcome Treatment
    1 Other