BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE IV CATHETER 20GA 1.88IN

    MDR report key: 10314454 · Received July 23, 2020

    Report

    Report Number
    8041187-2020-00432
    Event Type
    Malfunction
    Date Received
    July 23, 2020
    Date of Event
    June 20, 2020
    Report Date
    August 25, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    UDI-DI
    30382903812371
    PMA / PMN Number
    K151698
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL YES, D.10 RETURNED TO MANUFACTURER ON: 2020-07-13. H.6. INVESTIGATION SUMMARY: THREE PHOTOS AND ONE SAMPLE WAS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM VISUAL INSPECTION, A SMALL BLACK FIBER WAS OBSERVED ON THE CATHETER TIP, CONFIRMING THE CUSTOMER EXPERIENCE. 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. THE SAMPLE UNDERWENT TESTING FTIR (FOURIER TRANSFORM INFRARED SPECTROSCOPY) TESTING. THIS SHOWED THAT THE FIBER REASONABLY MATCHES WITH POLY(ETHYLENE TEREPHALATE). POLY(ETHYLENE TEREPHALATE) IS A THERMOPLASTIC POLYMER RESIN OF THE POLYESTER FAMILY AND IS USED IN SYNTHETIC FIBERS, CONTAINERS, THERMOFORMING IN MANUFACTURING, ENGINEERING RESINS, AND PACKAGING MATERIALS. THIS LIKELY CAME FROM A SMOCK WORN BY THE PRODUCTION TECHNICIANS. THE OLD SMOCKS HAVE BEEN CHANGED TO A NEW ONE. THE SMOCK / JUMPSUIT MATERIAL MAY HAVE DEGRADED DUE TO FREQUENT USE AND WASHING. THIS MOST PROBABLY CAUSED LOOSE FIBER AND THE LOOSE FIBER MAY HAVE DISLODGED AND MIGHT HAVE TRANSFERRED DURING PRODUCTION TO MATERIAL AT THE TUBE CUTTER, ISAM, TIPPING AND ICAM DURING MATERIAL TRANSFER AND WAS DEPOSITED ONTO THE CATHETER TUBING AS SEEN ON THE PICTURE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE¿ IV CATHETER 20GA 1.88IN CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "COMPLAINT FROM QUEEN MARY HOSPITAL. THE USER COMPLAINED THAT 1MM BLACK FOREIGN MATERIAL WAS FOUND ON THE SHEATH OF A NEW INTRAVENOUS CANNULA."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INSYTE¿ IV CATHETER 20GA 1.88IN CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "COMPLAINT FROM (B)(6). THE USER COMPLAINED THAT 1MM BLACK FOREIGN MATERIAL WAS FOUND ON THE SHEATH OF A NEW INTRAVENOUS CANNULA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782326 BD INSYTE IV CATHETER 20GA 1.88IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 381237 7324286 30382903812371

    Patients

    Seq Age Sex Outcome Treatment
    1 Other