BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 7307613 · Received March 1, 2018

    Report

    Report Number
    1710034-2018-00066
    Event Type
    Malfunction
    Date Received
    March 1, 2018
    Date of Event
    February 6, 2018
    Report Date
    February 10, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825234
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION RESULTS: SUMMARY: ONE HUNDRED UNUSED SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. UPON EXAMINATION, ALL OF THE UNITS WERE INTACT WITH NO VISIBLE DAMAGES. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THE UNUSED UNITS RECEIVED FOR THIS INCIDENT DID NOT DISPLAY ANY PHYSICAL OR MECHANICAL DAMAGES, THEREFORE, A ROOT CAUSE COULD NOT BE DETERMINED FOR THIS INCIDENT. CONCLUSION: DEVICE/BATCH HISTORY RECORD REVIEW: REVIEW OF DHR LOT #: 7202987, REVEALED ALL REQUIRED CHALLENGE SAMPLES AND TESTING WAS CONDUCTED PER SPECIFICATIONS AND IN ACCORDANCE WITH THE IN-PROCESS SAMPLING PLANS. REVIEW DISCLOSED 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 100 22GA BD INSYTE AUTOGUARD IV BLOOD CONTROL CATHETER UNITS WITHIN SEALED PACKAGES FROM LOT 7202987, THE UNITS WERE INSIDE DISPENSERS. ALL COMPONENTS WERE PRESENT AN INTACT WITH NO VISIBLE DAMAGE TO THE PACKAGING OR UNITS. VISUAL/MICROSCOPIC EXAMINATION: 100% VISUAL INSPECTION WAS PERFORMED. NO ANOMALIES OR DAMAGE TO THE CATHETER TUBING, WEDGE, SEPTUM OR ACTUATOR. NO DAMAGE WAS OBSERVED ON THE ADAPTER AND THE ACTUATOR AND THE SEPTUM WERE ON THE RIGHT POSITION. FLASHBACK TEST: THE TEST WAS CONDUCTED IN AN ATTEMPT TO REPRODUCE THE CUSTOMER EXPERIENCE. THE UNITS DEMONSTRATED ACCEPTABLE FLASHBACK; THE INITIAL FLASHBACK VISUALIZATION COULD BE SEEN VERY QUICKLY; THE FLUID TOOK LESS THAN ONE SECOND TO SHOW A VISIBLE FLOW THROUGH THE NOTCH. THERE WERE NO INDICATIONS OF OBSTRUCTION OR OCCLUSION PRESENT IN THE UNITS. INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: YES, THE USED UNITS PASSED ALL TESTING AND NO ANOMALIES OR DAMAGE WAS OBSERVED TO THE UNITS. CONCLUSIONS: THE UNITS DEMONSTRATED ACCEPTABLE FLASHBACK. THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR TO SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECT STATED IN THE EVENT DESCRIPTION. THE UNITS WERE ACCEPTABLE PER ALL TESTING AND OBSERVATIONS PERFORMED. THE RETURNED UNUSED UNITS DID NOT DISPLAY ANY ADVERSE CHARACTERISTICS THAT WOULD CONTRIBUTE TO THE DEFECT STATED IN THIS INCIDENT. DID THE EVALUATION CONFIRM THE CUSTOMER¿S EXPERIENCE WITH THE BD PRODUCT? NO; THE SUBJECT FAILURE RELATED TO THIS INVESTIGATION COULD NOT BE CONFIRMED. THE UNITS PERFORMED AS INTENDED DURING THE FLASHBACK TEST. WERE WE ABLE TO REPRODUCE THE CUSTOMER'S EXPERIENCE WITH THE BD PRODUCT? NO; REPRODUCTION OF THE CUSTOMER¿S EXPERIENCE OF SEPTUM DAMAGED/DEFECTIVE WAS NOT ACHIEVED WITH THE TESTING PERFORMED ON THE RETURNED UNUSED UNITS. WAS THE DEVICE USED FOR TREATMENT OR DIAGNOSIS? TREATMENT. ROOT CAUSE: RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: INDETERMINATE - THE UNUSED UNITS RECEIVED FOR THIS INCIDENT DID NOT DISPLAY ANY PHYSICAL OR MECHANICAL DAMAGE THAT WOULD CONTRIBUTE TO THE DEFECT STATED IN THE PRODUCT INCIDENT REPORT. THE REPORTED FAILURE COULD NOT BE IDENTIFIED OR CONFIRMED WITH THE RETURNED UNUSED UNITS; THEREFORE THIS INCIDENT IS INDETERMINATE. CORRECTIONS AND CAPA: CORRECTIVE ACTION PROJECT / CAPA (#): A DEFINITE ROOT CAUSE COULD NOT BE ESTABLISHED. 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. OTHER ACTION TAKEN: PRODUCT QUALITY IS EVALUATED DURING THE MANUFACTURING PROCESS WITH PRESCRIBED VARIABLE AND ATTRIBUTES INSPECTIONS. THESE INSPECTIONS ARE PERFORMED BY OPERATORS AND/OR PROCESS CONTROL TECHNICIANS TO ENSURE ANY GROSS PROCESS CHANGES ARE IDENTIFIED. IF DEFECTS ARE OBSERVED, DISPOSITION OF THE PRODUCT, ROOT CAUSE AND CORRECTIVE ACTION ARE APPLIED ACCORDING TO THE QUALITY CONTROL PLAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER, THE ¿VALVE THAT STOPS BLOOD FROM COMING OUT" FAILED. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148981 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7202987 30382903825234

    Patients

    Seq Age Sex Outcome Treatment
    1 Other