BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 7349768 · Received March 19, 2018

    Report

    Report Number
    1710034-2018-00095
    Event Type
    Malfunction
    Date Received
    March 19, 2018
    Date of Event
    February 23, 2018
    Report Date
    April 5, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814122
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: DEVICE/BATCH HISTORY RECORD REVIEW FINDINGS: THE LOT NUMBER WAS BUILT ON AFA LINE 4, FROM AUGUST 26, 2017 THRU AUGUST 30, 2017. REVIEW OF THE DHR REVEALED ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE IN-PROCESS SAMPLING PLANS. PER REVIEW IT WAS NOTED THAT THERE WERE NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT. SETUP AND IN PROCESS SAMPLING INCLUDE (NOT LIMITED TO); RETRACTION BY BUTTON ACTIVATION WERE PERFORMED ON VARIOUS STAGES THROUGHOUT THE PROCESS, ALL THE INSPECTIONS PASSED PER SPECIFICATIONS. NO SIGNIFICANT DISCOVERIES WERE FOUND. THE REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE DEFECT OF NEEDLE RETRACTION FAILURE. THE PEURA (END USER RISK ANALYSIS) WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT CURRENT RISK IS ACCEPTABLE. OCCURRENCE AND SEVERITY RANKINGS HAVE NOT CHANGED. OBSERVATIONS AND TESTING: RECEIVED A TOTAL OF 118 UNITS FROM LOT NUMBER 7220650, THE UNITS WERE RECEIVED AS FOLLOWS. 100 UNUSED UNITS WITHIN SEALED PACKAGES WERE RECEIVED ON 2 DISPENSERS. 16 UNUSED UNITS WITHIN SEALED PACKAGES WERE RECEIVED ON A PLASTIC BAG. 2 USED UNITS WERE RECEIVED ON OPEN PACKAGES, 1 OF THE UNITS WAS FULLY RETRACTED. NOTE: A SAMPLE SIZE OF 76 + THE 2 (USED) UNITS WERE USED FOR THE FOLLOWING EVALUATION: VISUAL/MICROSCOPIC EXAMINATION: ALL UNITS (78): NO PHYSICAL/MECHANICAL DAMAGE WAS OBSERVED TO THE SPRING, NEEDLE HUB OR GRIP. THERE WERE NO MISSING COMPONENTS OR EVIDENCE OF GLUE ON THE BUTTONS OR HUBS. FUNCTIONAL TEST (NEEDLE RETRACTION): UNUSED UNITS: THE NEEDLE COVERS WERE REMOVED, MANUALLY ROTATED THE CATHETER TIPS 360 DEGREES, THE CATHETER TUBING DID NOT ¿CANDY CANNED¿. THE WHITE BUTTONS WERE DEPRESSED AND THE NEEDLES RETRACTED MEETING NO RESISTANCE. RETRACTION WAS SUCCESSFUL. USED UNITS: RETRACTED UNIT: THE NEEDLE WAS PUT INTO THE OUT POSITION AND THE CATHETER BACK IN PLACE. THE NEEDLE REMAINED OUT OF THE BARREL UNTIL THE WHITE BUTTON WAS DEPRESSED. RETRACTION WAS SUCCESSFUL NON-RETRACTED UNIT: THE NEEDLE COVER WAS REMOVED, MANUALLY ROTATED THE CATHETER TIP 360 DEGREES, THE CATHETER TUBING DID NOT ¿CANDY CANNED¿. THE WHITE BUTTON WAS DEPRESSED AND THE NEEDLE RETRACTED MEETING NO RESISTANCE. RETRACTION WAS SUCCESSFUL. NO MECHANICAL/PHYSICAL DAMAGE WAS OBSERVED AND THE UNITS DEMONSTRATED A SUCCESSFUL RETRACTION WHEN TESTED IN THE LABORATORY ENVIRONMENT. THE DEFECT OF NEEDLE RETRACTION FAILURE AS STATED IN THE EVENT DESCRIPTION COULD NOT BE CONFIRMED WITH THE UNITS RETURNED FOR EVALUATION AND TESTING. ROOT CAUSE RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: INDETERMINATE. COMMENT: THE RETURNED REPRESENTATIVE UNITS DID NOT DISPLAY ANY ADVERSE CHARACTERISTICS THAT WOULD CONTRIBUTE TO THE DEFECT THE CUSTOMER EXPERIENCED. THE DEFECT DESCRIBED IN THE EVENT DESCRIPTION COULD NOT BE CONFIRMED OR REPLICATED WITH THE RETURNED UNITS. A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. CUSTOMER COMPLAINT TRENDS ARE EVALUATED ON A MONTHLY BASIS. IF THE TREND OF A SPECIFIC TYPE OF COMPLAINT WARRANTS A FORMAL CORRECTIVE ACTION, RESOURCES WILL BE ASSIGNED AT THAT TIME.

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAFETY MECHANISM ON A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER FAILED TO FUNCTION PROPERLY, LEAVING THE NEEDLE EXPOSED. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194395 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7226956 30382903814122

    Patients

    Seq Age Sex Outcome Treatment
    1 Other