BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE ¿ IV CATHETER WINGED

    MDR report key: 7298152 · Received February 26, 2018

    Report

    Report Number
    8041187-2018-00034
    Event Type
    Malfunction
    Date Received
    February 26, 2018
    Date of Event
    January 31, 2018
    Report Date
    March 14, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    UDI-DI
    30382903813446
    PMA / PMN Number
    K151698
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: 1 USED ACTUAL SAMPLE AND 1 UNUSED REPRESENTATIVE SAMPLE WERE RETURNED FOR INVESTIGATION. DEVICE HISTORY RECORD OF PACKAGED NEEDLE (PN) BATCH 7139088, CATALOGUE NUMBER 381344 AND ITS ASSEMBLED NEEDLE (AN) BATCHES 7111390 AND 7139120, PART NUMBER 8083545 WAS REVIEWED. NO QUALITY NOTIFICATION WAS RAISED FOR SIMILAR NONCONFORMANCE DURING THE PRODUCTION OF THIS BATCH. FIGURE: RETURNED SAMPLES. BOTH SAMPLES WERE SUBJECTED TOO VISUAL INSPECTION. NO ABNORMALITIES WERE OBSERVED ON BOTH RETURNED SAMPLES. FIGURE: NO ABNORMALITIES OBSERVED. THE OILY SUBSTANCES ON THE SURFACE OF BOTH CATHETERS WERE SUBJECTED TO FOURIER TRANSFORM INFRARED SPECTROSCOPY TEST. THE FTIR RESULTS SHOWED THAT THE OILY SUBSTANCE OF THE ACTUAL SAMPLE (SAMPLE IN ZIP LOCK BAG) HAD MATCHED THE CATHETER SOLVENT USED IN THE MANUFACTURING FACILITY. THE FTIR RESULTS SHOWED THAT THE OILY SUBSTANCE OF THE REPRESENTATIVE SAMPLE (SAMPLE IN UNIT PACKAGE) HAD MATCHED THE CATHETER SOLVENT USED IN THE MANUFACTURING FACILITY. THE NONCONFORMANCE CANNOT BE CONFIRMED AS THE OILY SUBSTANCES FROM BOTH RETURNED SAMPLES HAD MATCHED WITH THE CATHETER LUBRICANT USED IN THE MANUFACTURING FACILITY. INVESTIGATION CONCLUSION: THE ROOT CAUSE CANNOT BE DETERMINED AS THE OILY SUBSTANCES FROM BOTH RETURNED SAMPLES HAD MATCHED WITH THE CATHETER LUBRICANT USED IN THE MANUFACTURING FACILITY.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 WHILE A NURSE WAS ATTEMPTING TO REMOVE A BD INSYTE ¿ IV CATHETER WINGED, IT SEEMED TO STICK INSIDE THE VEIN MAKING IT DIFFICULT TO REMOVE. AN ANESTHETIST EXTRACTED IT FINDING ¿WHITE TRACES¿ OF GLUE ON THE CATHETER. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141722 BD INSYTE ¿ IV CATHETER WINGED INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 7139088 30382903813446

    Patients

    Seq Age Sex Outcome Treatment
    1 Other