BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 7151114 · Received December 28, 2017

    Report

    Report Number
    1710034-2017-00485
    Event Type
    Malfunction
    Date Received
    December 28, 2017
    Date of Event
    December 5, 2017
    Report Date
    December 10, 2017
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814238
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. RESULTS: INVESTIGATION SUMMARY: RECEIVED ONE UNUSED IAG 20GA UNIT IN SEALED PACKAGE FROM THE LOT NUMBER 6061736. OBSERVED THERE WAS NO MECHANICAL/PHYSICAL DAMAGE TO ANY OF THE COMPONENTS (SPRING, NEEDLE, HUB, OR GRIP) OR EVIDENCE OF ADHESIVE ON THE BUTTON OR HUB. PERFORMED THE HUB TWIST TEST THEN DEPRESSED THE BUTTON. THE RETRACTION WAS SUCCESSFUL, NO DELAYED REACTION WAS OBSERVED. INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: YES, THE RETURNED UNIT PROVIDED FOR EVALUATION MET AND PERFORMED PER THE REQUIRED MANUFACTURING SPECIFICATIONS. WAS THE DEVICE USED FOR TREATMENT OR DIAGNOSIS? TREATMENT. CONCLUSIONS: THE DEFECT NEEDLE RETRACTION FAILURE, AS STATED IN THE DESCRIPTION OF THE COMPLAINT WAS NOT CONFIRMED WITH THE RETURNED UNIT. THE RETURNED UNIT DID NOT DISPLAY ANY ADVERSE CHARACTERISTICS THAT WOULD CONTRIBUTE TO THE DEFECT THE CUSTOMER EXPERIENCED. THE DEFECT DESCRIBED IN THE INCIDENT REPORT COULD NOT BE CONFIRMED OR REPLICATED WITH THE RETURNED REPRESENTATIVE UNIT. THE ACTUAL UNIT DESCRIBED IN THE INCIDENT REPORT WAS NOT RETURNED FOR EVALUATION. DID THE EVALUATION CONFIRM THE CUSTOMER¿S EXPERIENCE WITH THE BD PRODUCT? NO; THE CUSTOMER EXPERIENCE WAS NOT CONFIRMED BASED ON THE EVALUATION AND TESTING THAT WAS PERFORMED ON THE RETURNED UNIT. WERE WE ABLE TO REPRODUCE THE CUSTOMER'S EXPERIENCE WITH THE BD PRODUCT? NO; REPRODUCTION OF THE CUSTOMER¿S EXPERIENCE WAS NOT ACHIEVED WITH THE TESTING PERFORMED ON THE RETURNED UNIT. RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: INDETERMINATE. COMMENT: THERE WAS NO DEFINITE PHYSICAL OR MECHANICAL EVIDENCE THAT CONFIRMED AND SUPPORTED MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECT OBSERVED IN THIS INCIDENT. ROOT CAUSE COULD NOT BE DETERMINED WITH THE INVESTIGATION FOR THIS INCIDENT. A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. A MANUFACTURING RELATED ROOT CAUSE COULD NOT BE IDENTIFIED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE ON A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER FAILED TO RETRACT POST USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930121 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 6061736 30382903814238

    Patients

    Seq Age Sex Outcome Treatment
    1 Other