BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8879183 · Received August 9, 2019

    Report

    Report Number
    1710034-2019-00869
    Event Type
    Malfunction
    Date Received
    August 9, 2019
    Date of Event
    July 16, 2019
    Report Date
    September 4, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814443
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT. RECEIVED A TOTAL OF TWENTY SEVEN (27) UNUSED REPRESENTATIVE 18GA BD INSYTE AUTOGUARD UNITS WITHIN UNDAMAGED SEALED PACKAGES FROM LOT 9071656: ALL COMPONENTS WERE PRESENT AND INTACT. VISUAL / MICROSCOPIC EVALUATION): VISUAL OBSERVATION OF ALL 27 UNITS DEMONSTRATED NO INDICATIONS OF ANY TYPE OF ANOMALIES, DAMAGE OR EXCESS ADHESIVE OR GEL THAT WOULD HINDER OR RESTRICT A SUCCESSFUL RETRACTION. FUNCTIONAL (NEEDLE ACTIVATION): DEPRESSED THE ACTIVATION BUTTON; THE NEEDLE FULLY RETRACTED ON ALL 27 UNITS MEETING NO RESISTANCE. ALL UNITS WERE ACCEPTABLE. CONCLUSION: BASED ON THE OBSERVATION AND/OR TESTING CONDUCTED ON THE RETURNED REPRESENTATIVE UNITS, THE REPORTED DEFECT WAS NOT IDENTIFIED OR CONFIRMED AND A ROOT CAUSE WAS NOT ESTABLISHED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETERS WOULD NOT RETRACT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ED RN REPORTED THAT HER ANGIOCATH NEEDLE DID NOT RETRACT. (BD INSYTE AUTOGUARD). NO NEEDLESTICK. USED PRODUCT PLACED INTO SHARPS CONTAINER. THIS HAPPENED TWICE IN ED WITH SAME DEVICE MODEL AND SAME LOT NUMBER.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: 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 2 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETERS WOULD NOT RETRACT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ED RN REPORTED THAT HER ANGIOCATH NEEDLE DID NOT RETRACT. (BD INSYTE AUTOGUARD). NO NEEDLESTICK. USED PRODUCT PLACED INTO SHARPS CONTAINER. THIS HAPPENED TWICE IN ED WITH SAME DEVICE MODEL AND SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674018 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9071656 30382903814443

    Patients

    Seq Age Sex Outcome Treatment
    1 Other