BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH PLUS CATHETER

    MDR report key: 7004016 · Received November 6, 2017

    Report

    Report Number
    8041187-2017-00158
    Event Type
    Malfunction
    Date Received
    November 6, 2017
    Date of Event
    October 17, 2017
    Report Date
    December 10, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    K950301
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: RETURNED ACTUAL SAMPLES WERE NOT DECONTAMINATED. VISUAL INSPECTION WAS PERFORMED ON ALL THE SAMPLES. THE SUMMARY OF THE RESULTS ARE STATED AS BELOW. NOTE THAT 2 NON-BO 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. RETURN SAMPLE SHOWED: PHOTO SHOWED REPORTED DEFECT. RETURNED SAMPLE SHOWED REPORTED DEFECT. DHR REVIEW: DEVICE HISTORY RECORD OF PACKAGED NEEDLE (PN) BATCH 7111357, CATALOGUE NUMBER 382412 AND ITS ASSEMBLED NEEDLE (AN) BATCHES 7111413, 7111395 AND 7111412, PART NUMBER 8365076 WAS REVIEWED. NO QUALITY NOTIFICATION WAS RAISED FOR SIMILAR NONCONFORMANCE DURING THE PRODUCTION OF THIS BATCH. THE PREVENTIVE MAINTENANCE, CALIBRATION AND EQUIPMENT HISTORY RECORDS WERE REVIEWED. NO ABNORMALITY WAS OBSERVED ON THE RECORDS. CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. WHITE FM AND EMBEDDED FM WAS FOUND. WAS PRODUCT WITHIN SPECIFICATION? NO. ROOT CAUSE: LOOSE WHITE POWDERY FM WAS FOUND. THE WHITE POWDERY FM IS MORE LIKELY FROM THE TOP WEB MATERIAL. BROWN EMBEDDED FM WAS FOUND IN THE NEEDLE COVER. PROBABLE ROOT CAUSE: MATERIAL. CAPA NUMBER: N/A AT THIS TIME NO CAPA IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED BEFORE USE THAT THERE WAS FOREIGN PARTICULATES IN THE BD ANGIOCATH PLUS CATHETER-382412. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784664 BD ANGIOCATH PLUS CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 7111357

    Patients

    Seq Age Sex Outcome Treatment
    1 Other