BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ PLUS

    MDR report key: 7914147 · Received September 27, 2018

    Report

    Report Number
    8041187-2018-00340
    Event Type
    Malfunction
    Date Received
    September 27, 2018
    Date of Event
    September 5, 2018
    Report Date
    October 2, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE PHOTO WAS RETURNED FOR INVESTIGATION. FIBER FM WAS OBSERVED IN THE RETURNED PHOTO. ONE ACTUAL SAMPLE IN OPENED PACKAGING WAS RETURNED FOR INVESTIGATION. THE ACTUAL SAMPLE WAS SUBJECTED TO VISUAL INSPECTION. LOOSE FIBER FM WAS OBSERVED ON THE CATHETER OF THE RETURNED SAMPLE. THE SAMPLE WAS SENT FOR FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS. THE FTIR RESULTS SHOWED THAT THE SPECTRUM OF THE FIBER WAS FOUND TO BE CELLULOSE. CELLULOSE MATERIAL IS COMMONLY FOUND IN PAPER, WOOD, WIPER, FABRIC INDUSTRY AND SIMILAR MATERIALS. ONE PHOTO WAS RETURNED FOR INVESTIGATION. FIBER FM WAS OBSERVED IN THE RETURNED PHOTO. ONE ACTUAL SAMPLE IN OPENED PACKAGING WAS RETURNED FOR INVESTIGATION. THE ACTUAL SAMPLE WAS SUBJECTED TO VISUAL INSPECTION. LOOSE FIBER FM WAS OBSERVED ON THE CATHETER OF THE RETURNED SAMPLE. THE SAMPLE WAS SENT FOR FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS. THE FTIR RESULTS SHOWED THAT THE SPECTRUM OF THE FIBER WAS FOUND TO BE CELLULOSE. CELLULOSE MATERIAL IS COMMONLY FOUND IN PAPER, WOOD, WIPER, FABRIC INDUSTRY AND SIMILAR MATERIALS. DEVICE HISTORY RECORDS WERE REVIEWED. PACKAGED NEEDLE BATCH 8082186, CATALOGUE NUMBER 382444 AND ITS ASSEMBLED NEEDLE BATCHES 8082106 AND 8082109, PART NUMBER 8301333 SHOWED NO QUALITY NOTIFICATIONS OR ABNORMALITY FOR SIMILAR NONCONFORMANCE WERE RAISED. UPON FURTHER INVESTIGATION, THE FIBER COULD HAVE BEEN TRANSFERRED FROM THE MANUFACTURING ENVIRONMENT DURING PRODUCT HANDLING OR THE ASSEMBLY PROCESS. JOB AID FOR HOUSEKEEPING STANDARD IN INSYTE ASSEMBLY AND PACKAGING PROCESS HAD BEEN ESTABLISHED. A COMMUNICATION WILL BE CONDUCTED TO ALL MANUFACTURING ASSOCIATES TO RAISE AWARENESS ON BOTH NONCONFORMANCE, PROPER GMP AND HOUSEKEEPING PROCEDURES. (B)(4) IS IN PLACE TO INVESTIGATE THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS THREAD-LIKE FOREIGN MATTER ON THE CANNULA OF THE BD ANGIOCATH PLUS. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    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 THAT THERE WAS THREAD-LIKE FOREIGN MATTER ON THE CANNULA OF THE BD ANGIOCATH¿ PLUS. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755587 BD ANGIOCATH¿ PLUS INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 8082186

    Patients

    Seq Age Sex Outcome Treatment
    1 Other