BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ PLUS

    MDR report key: 7004186 · Received November 6, 2017

    Report

    Report Number
    8041187-2017-00157
    Event Type
    Malfunction
    Date Received
    November 6, 2017
    Date of Event
    October 12, 2017
    Report Date
    December 7, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    K984059
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A TOTAL OF 206 SAMPLES WERE RETURNED IN DIFFERENT PACKAGING. RETURNED SAMPLES, RETURNED SAMPLES ¿ NON-BD PRODUCTS A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 7111357. A MANUFACTURING REVIEW REVEALED NO ABNORMALITIES WITH PREVENTATIVE MAINTENANCE, CALIBRATION, OR EQUIPMENT THAT COULD HAVE INFLUENCED THE CUSTOMER'S REPORTED ISSUE. VISUAL INSPECTION WAS PERFORMED ON ALL THE SAMPLES. THE SUMMARY OF THE RESULTS ARE STATED AS BELOW. 90, NOT IN ANY PRIMARY PACKAGING, WHITE FM = 5 PCS EMBEDDED FM = 1 PC. 50, IN OPENED PRIMARY PACKAGING, WHITE FM = 2 PCS EMBEDDED FM = 2 PCS. 50, IN OPENED PRIMARY PACKAGING, EMBEDDED FM = 1 PC. 14, IN OPENED PRIMARY PACKAGING, NO FM FOUND. NOTE THAT 2 NON-BD PRODUCTS WERE RETURNED IN OPENED PACKAGING THAT WERE STICK ON THE SHELF CARTON. BROWN EMBEDDED FM WAS FOUND IN THE NEEDLE COVER. LOOSE WHITE POWDERY FM WAS FOUND ON THE NEEDLE COVER. EMBEDDED FM AND WHITE FM FOUND LOOSE WHITE POWDERY FM WAS FOUND. THE WHITE POWDERY FM IS MORE LIKELY FROM THE TOP WEB MATERIAL. A (B)(4) HAS BEEN ISSUED TO THE TOP WEB SUPPLIER. BROWN EMBEDDED FM WAS FOUND IN THE NEEDLE COVER. A (B)(4) HAS BEEN ISSUED TO THE NEEDLE COVER SUPPLIER FOR FURTHER INVESTIGATION.

    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 DURING USE OF THE BD ANGIOCATH PLUS , THERE WERE FOREIGN PARTICLES. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784666 BD ANGIOCATH¿ PLUS INTRAVENOUS CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 7111357

    Patients

    Seq Age Sex Outcome Treatment
    1 Other