BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL

    MDR report key: 7060650 · Received November 27, 2017

    Report

    Report Number
    1710034-2017-00409
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    November 3, 2017
    Report Date
    November 8, 2017
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903825233
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE REPORTED BATCH NUMBER. FOUR SAMPLE UNITS WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. UPON EXAMINATION, NO MECHANICAL OR PHYSICAL DAMAGE WAS OBSERVED ON ANY OF THE COMPONENTS. A BLOOD ESCAPE TIME TEST WAS PERFORMED, THE TESTING FLUID DID NOT LEAK OUT OF THE ADAPTERS BEFORE THE TIME EXPIRED. BASED ON THE INVESTIGATION RESULTS, BD WAS UNABLE TO CONFIRM THE REPORTED DEFECT OF LEAKAGE AND THEREFORE, A ROOT CAUSE COULD NOT BE DETERMINED. THE CORRECTIVE ACTION STATEMENT IS APPROVED/AUTHORIZED AND FINAL REVIEW OF THE COMPLAINT WILL BE CONDUCTED BY DESIGNATED COMPLAINT HANDLING UNIT. AS REPORTED CODE: LEAKAGE BEYOND THE SEPTUM DHR REVIEW WAS PERFORMED ON THE FOLLOWING LOT NUMBER: 7212827 ¿ THE LOT NUMBER WAS BUILT AND PACKAGED ON AFA LINE 11, FROM AUGUST 6, 2017 THRU AUGUST 10, 2017. PER REVIEW OF THE DHR IT WAS CONCLUDED THAT 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. IN PROCESS SAMPLES WERE PERFORMED ON VARIOUS STAGES THROUGHOUT THE PROCESS, ALL THE INSPECTIONS PASSED PER SPECIFICATIONS. NO SIGNIFICANT DISCOVERIES WERE FOUND. QN / SAP DATABASE REVIEW: NO. THE PEURA (END USER RISK ANALYSIS): YES REASON: THE PEURA IS REQUIRED FOR ALL MDR REPORTABLE INVESTIGATIONS. FINDINGS: RM5835 REV 11 VERSION I WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT DUE TO LOW OCCURRENCE, CURRENT RISK IS ACCEPTABLE. VISUAL ANALYSIS OBSERVATIONS AND TESTING: RECEIVED FOUR UNUSED REPRESENTATIVE IAG/BC 22 GA UNITS IN SEALED PACKAGES FROM THE LOT NUMBER 7212827. VISUAL/MICROSCOPIC EXAMINATION: NO MECHANICAL/PHYSICAL DAMAGE WAS OBSERVED TO ANY OF THE COMPONENTS. THE ACTUATOR AND SEPTUM WERE PROPERLY SEATED. LEAKAGE BEYOND THE SEPTUM: BLOOD ESCAPE TIME TEST WAS PERFORMED. THE TESTING FLUID DID NOT LEAK OUT OF THE ADAPTERS BEFORE THE TIMER EXPIRED. INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: YES. THE RETURNED UNITS PROVIDED FOR EVALUATION MET MANUFACTURING SPECIFICATIONS WITH REGARDS FOR THE REPORTED INCIDENT. CONCLUSIONS: THE DEFECT LEAKAGE BEYOND THE SEPTUM, AS STATED AS THE REPORTED CODE WAS NOT CONFIRMED WITH THE RETURNED UNITS. THE RETURNED UNITS DID NOT DISPLAY ANY ADVERSE CHARACTERISTICS THAT WOULD CONTRIBUTE TO LEAKAGE BEYOND THE SEPTUM. THE DEFECT DESCRIBED IN THE INCIDENT REPORT COULD NOT BE CONFIRMED OR REPLICATED WITH THE RETURNED UNITS. THE UNIT DESCRIBED IN THE INCIDENT REPORT WAS NOT RETURNED FOR EVALUATION THEREFORE; A DEFINITE CAUSE CANNOT BE ASSIGNED AT THIS TIME. THE CUSTOMER EXPERIENCED WAS NOT CONFIRMED BASED ON THE EVALUATION AND TESTING THAT WAS PERFORMED ON THE RETURNED UNIT. REPRODUCTION OF THE CUSTOMER¿S EXPERIENCE WAS NOT ACHIEVED WITH THE TESTING PERFORMED ON THE RETURNED UNIT. CORRECTIVE ACTION PROJECT / CAPA (#): A ROOT CAUSE COULD NOT BE IDENTIFIED. A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING USE OF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER THE NURSE STATES THEY ARE FAILING IN BLOOD CONTROL. WHEN STARTING THE IV, THEY LEAK IF YOU DON¿T APPLY PRESSURE AT THE SITE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840472 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL SHIELDED IV CATHETER FOZ BECTON DICKINSON 7212827 00382903825233

    Patients

    Seq Age Sex Outcome Treatment
    1 Other