BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 12254811 · Received July 30, 2021

    Report

    Report Number
    1710034-2021-00645
    Event Type
    Malfunction
    Date Received
    July 30, 2021
    Date of Event
    July 1, 2021
    Report Date
    September 7, 2021
    Product Code
    FOZ
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: ONE UNUSED 22G X 1.00 IN. INSYTE AUTOGUARD WINGED DEVICE ALONG WITH OPENED PACKAGING FOR LOT: 0254236 AND FOUR PHOTOS WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THE NEEDLE WAS BENT, THERE WERE MULTIPLE SCRATCHES ON THE INTERIOR OF THE NEEDLE COVER, AND THERE WAS BLACK FOREIGN MATTER ON THE CATHETER TIP, NEEDLE TIP, CATHETER TUBING AND NEEDLE COVER. THE DEFECT OF NEEDLE BENT WAS CONFIRMED. THE FOREIGN MATTER WAS VERIFIED TO NOT BE EMBEDDED AS IT MOVED WHEN PUSHED WITH TWEEZERS. THE CUSTOMER¿S REPORTED DEFECT OF FOREIGN MATTER WAS VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. MICROSCOPIC INSPECTION WAS PERFORMED ON THE BLACK FOREIGN MATERIAL. THE MATERIAL REFLECTED A SMALL AMOUNT OF LIGHT AND, EXCEPT FOR THE MATERIAL ON THE NEEDLE COVER, THE SURFACE WAS SMOOTH WITH SPARSE CRACKS LOCATED WHERE THE MATERIAL SEPARATED. THE FOREIGN MATERIAL ON THE NEEDLE COVER HAD AN UNEVEN SURFACE BUT WAS OTHERWISE SIMILAR TO THE FOREIGN MATERIAL SEEN ON THE REST OF THE COMPONENTS. THE FOREIGN WAS SENT FOR FURTHER MATERIAL ANALYSIS TO DETERMINE WHAT THE FOREIGN MATERIAL MAY BE COMPOSED OF. FURTHER ANALYSIS SHOWED THAT THE FOREIGN MATERIAL WAS MOST LIKELY A COMBINATION OF POLYETHYLENE, WAX (CALCIUM STEARATE / PARAFFIN BLEND) AND DC360 SILICONE. SILICONE IS AN EXPECTED MATERIAL AS THE CATHETER IS DIPPED IN LUBRICANT WHICH IS TYPICALLY IDENTIFIED AS DC360 SILICONE DURING MATERIAL ANALYSIS. SINCE THE SAMPLE WAS RETURNED IN OPENED PACKAGING IT IS IMPOSSIBLE TO DETERMINE IF THE TWO REMAINING IDENTIFIED COMPONENTS ORIGINATED DURING MANUFACTURING OR IN THE USER ENVIRONMENT. GIVEN THE LOCATION OF THE FOREIGN MATTER AND THE FACT THAT AN UNBROKEN PIECE OF THE MATERIAL WAS FOUND SITTING BETWEEN THE CATHETER TIP AND THE NEEDLE TIP, IT IS LIKELY THAT IF THE DEFECT WAS PRODUCED IN MANUFACTURING IT WOULD HAVE OCCURRED AFTER THE NEEDLE IS INSERTED INTO THE CATHETER ASSEMBLY, BUT BEFORE THE NEEDLE COVER WAS PLACED. DURING THIS TIME WINDOW THERE ARE NO KNOWN SOURCES OF POLYETHYLENE OR WAX. THIS LEAVES ENVIRONMENTAL FACTORS AS POTENTIAL CONTRIBUTORS TO THE REPORTED DEFECT. MAINTENANCE, CLEANING, AND ORGANIZING ARE ALL PERFORMED TO HELP MITIGATE THE RISK FROM THIS TYPE OF DEFECT. ADDITIONALLY, IT IS POSSIBLE THAT SOILED LUBRICANT COULD HAVE INTRODUCED THE FOREIGN MATERIAL. HOWEVER, NO QNS RELATING TO THE LUBRICANT WERE FOUND. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT: SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER EXPERIENCED FOREIGN MATTER ON THE DEVICE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FM: THE CATHETER TIP LOOKS BLACK.

    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 THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER EXPERIENCED FOREIGN MATTER ON THE DEVICE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FM: THE CATHETER TIP LOOKS BLACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1151378 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ 0254236

    Patients

    Seq Age Sex Outcome Treatment
    1