BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 7400689 · Received April 5, 2018

    Report

    Report Number
    1710034-2018-00160
    Event Type
    Malfunction
    Date Received
    April 5, 2018
    Date of Event
    February 6, 2018
    Report Date
    April 10, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818129
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: LOT ANALYSIS REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES AND TESTING WAS CONDUCTED PER SPECIFICATIONS AND IN ACCORDANCE WITH THE IN-PROCESS SAMPLING PLANS. IN PROCESS SAMPLES FOR FOREIGN/NON FOREIGN MATERIAL, PARTICULATE LOOSE OR EMBEDDED WERE CONDUCTED AT VARIOUS STAGES THROUGHOUT THE PROCESS, ALL THE INSPECTIONS PASSED PER SPECIFICATIONS. NO SIGNIFICANT DISCOVERIES WERE DISCLOSED. DHR REVIEW DISCLOSED NO INDICATION OF THE ALLEGED DEFECT AS THERE WERE NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT STATED IN THE PR. VISUAL ANALYSIS RECEIVED ONE 24G BD INSYTE AUTOGUARD IV CATHETER UNIT ACCOMPANIED WITHIN AN OPENED PACKAGE FROM LOT 7030929. THE UNIT HAD ALL COMPONENTS PRESENT. THE NEEDLE/HUB WAS PARTIALLY RETRACTED WITHIN THE SAFETY SHIELD (BARREL) AND BENT NEAR THE TIP. THE NEEDLE WAS SLIGHTLY RETRACTED BACK WITHIN THE CATHETER WHICH CAUSED THE TUBING TO SLIGHTLY CURVE IN THE AREA OF THE BEND AND CRINKLE. THE ACTIVATION BUTTON WAS COMPLETELY DEPRESSED. NO OTHER ANOMALIES OR DAMAGE WAS OBSERVED. VISUAL/MICROSCOPIC EXAMINATION: USING CAUTION; REMOVED THE PROTECTIVE NEEDLE COVER. OBSERVED THE NEEDLE WAS BENT AT THE NOTCH. OBSERVED THERE WERE CORRESPONDING SCRATCHES/MARKINGS WITHIN THE PROTECTIVE NEEDLE COVER. CONCLUSIONS: CONFIRMATION OF THE DEFECT OF CATHETER BENT, AS STATED IN THE PIR, WAS CONCLUSIVE BASED ON THE OBSERVATIONS OF THE UNIT PROVIDED FOR THIS INCIDENT. IT WAS CONFIRMED THAT THE CANNULA WAS BENT AT THE NOTCH WITH CORRESPONDING SCRATCHES WITHIN THE NEEDLE COVER. ROOT CAUSE: RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: MANUFACTURING ¿ BASED ON THE FINDINGS RESULTING FROM THE EVALUATION OF THE UNIT AND PHOTOS PROVIDED FOR THIS INCIDENT; THE ROOT CAUSE OF THE DEFECT WAS ATTRIBUTED TO THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (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 NEEDLE ON A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER WAS FOUND BENT CAUSING AN INCOMPLETE NEEDLE RETRACTION. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244390 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7030929 00382903818129

    Patients

    Seq Age Sex Outcome Treatment
    1 Other