BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ PLUS IV CATHETER

    MDR report key: 7671094 · Received July 9, 2018

    Report

    Report Number
    8041187-2018-00235
    Event Type
    Malfunction
    Date Received
    July 9, 2018
    Date of Event
    May 10, 2018
    Report Date
    August 17, 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

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE PHOTO WAS RETURNED FOR INVESTIGATION. A LUMP WAS OBSERVED IN THE RETURNED PHOTO. TWO ACTUAL SAMPLES WERE RETURNED FOR INVESTIGATION. THE ACTUAL SAMPLES WERE SUBJECTED TO VISUAL INSPECTION. CLEAR AND TRANSPARENT FIBER WAS OBSERVED ON BOTH RETURNED SAMPLES. THE CLEAR AND TRANSPARENT FIBERS WERE SUBJECTED TO FOURIER TRANSFORM INFRARED SPECTROSCOPY TEST. THE FTIR RESULTS SHOWED THAT THE SPECTRUM OF THE CLEAR AND TRANSPARENT FIBER OF SAMPLE 1 HAD MATCHED THE SPECTRUM OF POLYURETHANE. THE FTIR RESULTS SHOWED THAT THE SPECTRUM OF THE CLEAR AND TRANSPARENT FIBER OF SAMPLE 2 HAD MATCHED THE SPECTRUM OF CELLULOSE. CLEAR AND TRANSPARENT FIBER WAS OBSERVED ON BOTH RETURNED SAMPLES. POLYURETHANE: THE CATHETER IS OF POLYURETHANE MATERIAL. THE FIBER COULD HAVE BEEN TRANSFERRED FROM THE MANUFACTURING ENVIRONMENT DURING THE MANUFACTURING PROCESS. CELLULOSE: CELLULOSE MATERIAL IS COMMONLY FOUND IN PAPER, WOOD, WIPER, FABRIC INDUSTRY AND SIMILAR MATERIALS. UPON FURTHER INVESTIGATION, THE FIBER COULD HAVE BEEN TRANSFERRED FROM THE MANUFACTURING ENVIRONMENT DURING HANDLING OR THE ASSEMBLY PROCESS. DHR REVIEW OF PACKAGED NEEDLE BATCH 8082142, CATALOGUE NUMBER 382412 AND ITS ASSEMBLED NEEDLE BATCHES 8082112 AND 8053390, PART NUMBER 8365076 SHOWED NO COMPLAINTS FOR SIMILAR NONCONFORMANCE. NO QUALITY NOTIFICATION WAS RAISED AND NO ABNORMALITY SHOWED ON PREVENTIVE MAINTENANCE, CALIBRATION AND EQUIPMENT HISTORY RECORDS. 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.

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER; DEVICE SINGLE USE?: NO; DEVICE RETURNED TO MANUFACTURER: YES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN A BD ANGIOCATH¿ PLUS IV CATHETER. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN A BD ANGIOCATH PLUS IV CATHETER. 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 AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN A BD ANGIOCATH¿ PLUS IV CATHETER. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511611 BD ANGIOCATH¿ PLUS IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 8082142

    Patients

    Seq Age Sex Outcome Treatment
    1 Other