BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8917231 · Received August 21, 2019

    Report

    Report Number
    1710034-2019-00910
    Event Type
    Malfunction
    Date Received
    August 21, 2019
    Date of Event
    August 1, 2019
    Report Date
    September 26, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814344
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD RECEIVED 3 INSYTE AUTOGUARD 20 GAUGE UNITS FROM LOT 9071613 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNIT AND OBSERVED SILICONE LUBRICANT VISIBLE ON THE BEVEL OF THE NEEDLES. SILICONE LUBRICANT WAS USED DURING THE MANUFACTURING PROCESS TO MINIMIZE THE INSERTION AND THREADING FORCES REQUIRED DURING USE. BASED OFF THE VISUAL INSPECTION THE ENGINEER WAS ABLE TO VERIFY THE REPORTED ISSUE. HOWEVER, THE SILICONE LUBRICANT WOULD NOT AFFECT THE FIT OR FORM OF THE UNIT AND WOULD HELP WITH THE INSERTION PROCESS.

    Description of Event or Problem · 0

    MATERIAL NO. 381434 BATCH NO. 9071613. IT WAS REPORTED THAT BEFORE USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THERE WAS FOREIGN MATTER ON THE IV NEEDLE BEVEL. SAMPLING OF ADDITIONAL IV CATHETERS FROM THE SAME LOT # REVEALED TWO OF EIGHT WITH SIMILAR DEFECT PRESENT FOR A TOTAL OF THREE WITH THIS ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRIOR TO IV INSERTION, A NURSE NOTICED A PERIPHERAL IV 9PIV) HAD A FOREIGN OBJECT ATTACHED TO THE IV NEEDLE BEVEL. SAMPLING OF ADDITIONAL IV CATHETERS FROM THE SAME LOT # REVEALED TWO OF EIGHT WITH SIMILAR DEFECT PRESENT.

    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

    MATERIAL NO. 381434 BATCH NO. 9071613. IT WAS REPORTED THAT BEFORE USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THERE WAS FOREIGN MATTER ON THE IV NEEDLE BEVEL. SAMPLING OF ADDITIONAL IV CATHETERS FROM THE SAME LOT # REVEALED TWO OF EIGHT WITH SIMILAR DEFECT PRESENT FOR A TOTAL OF THREE WITH THIS ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRIOR TO IV INSERTION, A NURSE NOTICED A PERIPHERAL IV 9PIV) HAD A FOREIGN OBJECT ATTACHED TO THE IV NEEDLE BEVEL. SAMPLING OF ADDITIONAL IV CATHETERS FROM THE SAME LOT # REVEALED TWO OF EIGHT WITH SIMILAR DEFECT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712500 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9071613 30382903814344

    Patients

    Seq Age Sex Outcome Treatment
    1 Other