BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH PLUS

    MDR report key: 7060054 · Received November 27, 2017

    Report

    Report Number
    8041187-2017-00177
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    October 4, 2017
    Report Date
    December 14, 2017
    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 · 1

    INVESTIGATION SUMMARY: 2 PHOTO WAS RETURNED FOR INVESTIGATION. THREAD-LIKE FM WAS OBSERVED IN THE RETURNED PHOTO. 4 ACTUAL SAMPLES WITHOUT PACKAGING AND NEEDLE COVER AND 88 REPRESENTATIVE SAMPLES WITHOUT PACKAGING WERE RETURNED FOR INVESTIGATION. THE ACTUAL SAMPLES WERE RETURNED BOUND TOGETHER BY ADHESIVE TAPE. ACTUAL SAMPLES. REPRESENTATIVE SAMPLES: FIGURE 1: RETURNED SAMPLES. THE ACTUAL SAMPLES WERE SUBJECTED TO VISUAL INSPECTION, WITHOUT REMOVING THE ADHESIVE TAPE. THREAD-LIKE FM WAS OBSERVED ON THE TAPE OF THE ACTUAL SAMPLES. THE REPRESENTATIVE SAMPLES WERE SUBJECTED TO VISUAL INSPECTION. THREAD-LIKE FM WAS OBSERVED ON THE CATHETERS OF 28 REPRESENTATIVE SAMPLES. FM ON TAPE; FM ON REPRESENTATIVE SAMPLES. FIGURE 2: FM ON RETURNED SAMPLES. THE THREAD-LIKE FM FROM 3 RANDOM REPRESENTATIVE SAMPLES LABELLED ¿2¿, ¿4¿, AND ¿6¿ WERE SUBJECTED TO FOURIER TRANSFORM INFRARED SPECTROSCOPY TEST. THE FTIR RESULTS SHOWED THAT THE SPECTRUM OF FM FROM SAMPLE LABELLED ¿2¿ MATCHED THE SPECTRUM OF PROTEIN FIBER. THE FTIR RESULTS SHOWED THAT THE SPECTRUM OF FM FROM SAMPLE LABELLED ¿4¿ MATCHED THE SPECTRUM OF CELLULOSE. THE FTIR RESULTS SHOWED THAT THE SPECTRUM OF FM FROM SAMPLE LABELLED ¿6¿ MATCHED THE SPECTRUM OF PROTEIN FIBER AND ALSO INDICATED PRESENCE OF SILICONE PEAKS IN THE SPECTRUM. INVESTIGATION CONCLUSION: THREAD-LIKE FM WAS OBSERVED ON THE TAPE OF THE ACTUAL SAMPLES AND 28 OF THE REPRESENTATIVE SAMPLES. ROOT CAUSE DESCRIPTION: CELLULOSE IS COMMONLY USED IN PAPER AND FABRIC INDUSTRY. UPON FURTHER INVESTIGATION, THE THREAD-LIKE FM COULD HAVE BEEN TRANSFERRED FROM THE MANUFACTURING ENVIRONMENT DURING 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 THE NONCONFORMANCE, PROPER GMP AND HOUSEKEEPING PROCEDURES. THE TREND OF THE NONCONFORMANCE WILL BE CONTINUALLY MONITORED. PROTEIN FIBER SILK IS A TYPE OF NATURAL PROTEIN COMPOUND WHICH CAN BE FOUND IN TEXTILES. NO SILK WAS USED IN THE MANUFACTURING PROCESS. SILICONE PEAKS SILICONE WAS USED IN THE CATHETER LUBRICATION PROCESS IN THE MANUFACTURING FACILITY. A REVIEW OF THE DEVICE HISTORY AND MANUFACTURING RECORDS REVEALS NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6113183. THE PROBABLE ROOT CAUSE OF THE NONCONFORMANCE COULD BE DUE TO THE CATHETER SURFACE CONTACT WITH THE LUBRICATED DROPPED PARTS ON THE MESHING TRAY AT THE LUBRICATION STATION. THE MESHING TRAY HAS BEEN MODIFIED TO REMOVE THE POSSIBILITY OF CATHETER SURFACE CONTACT WITH THE LUBRICATED DROPPED PARTS. THE AFFECTED BATCH WAS PRODUCED BEFORE THE IMPLEMENTATION OF THE ABOVE ACTION. RATIONALE: A COMMUNICATION WILL BE CONDUCTED TO ALL MANUFACTURING ASSOCIATES TO RAISE AWARENESS ON THE NONCONFORMANCE, PROPER GMP AND HOUSEKEEPING PROCEDURES.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER FAX #: (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 THE BD ANGIOCATH PLUS HAD AN UNKNOWN FOREIGN BODY IN FOUND IN THE CATHETER TUBE. FOUND BEFORE USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838896 BD ANGIOCATH PLUS INTRAVENOUS CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 6113183

    Patients

    Seq Age Sex Outcome Treatment
    1 Other