BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 7241238 · Received February 5, 2018

    Report

    Report Number
    1710034-2018-00016
    Event Type
    Malfunction
    Date Received
    February 5, 2018
    Date of Event
    January 9, 2018
    Report Date
    February 9, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814344
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: LOT ANALYSIS: PER REVIEW OF THE DHR IT WAS CONCLUDED THAT ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE SET-UP AND 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. SET-UP AND IN PROCESS SAMPLES (INCLUDING BUT NOT LIMITED TO) FOR DAMAGED COMPONENT (GRIP, BUTTON, SPRING, HUB), NEEDLE RETRACTION BY BUTTON ACTIVATION AND ADHESIVE OVERFILLED/DRIP AS WELL AS PERIODIC CLEANING/ALIGNMENT OF THE GLUE GRIPPERS WERE PERFORMED ON VARIOUS STAGES THROUGHOUT THE PROCESS, ALL THE INSPECTIONS PASSED PER SPECIFICATIONS. NO SIGNIFICANT DISCOVERIES WERE FOUND. QN / SAP DATABASE REVIEW: NO. REASON: QN/SAP DATABASE REVIEW IS NOT REQUIRED FOR LEVEL A INVESTIGATIONS PER CPR ¿ 071. FINDINGS: N/A. THE PEURA (END USER RISK ANALYSIS): YES. REASON: THE PEURA IS REQUIRED FOR ALL MDR REPORTABLE INVESTIGATIONS. FINDINGS: RM5835 REV 12 VERSION J 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 A TOTAL OF 67 UNITS FROM LOT NUMBER 7220650, THE UNITS WERE RECEIVED INSIDE DISPENSERS AND SEALED PACKAGES, THEIR COMPONENTS WERE INTACT. VISUAL/MICROSCOPIC EXAMINATION: NO MECHANICAL/PHYSICAL 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): 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. INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: YES. NO MECHANICAL/PHYSICAL DAMAGE WAS OBSERVED AND THE UNITS DEMONSTRATED A SUCCESSFUL RETRACTION WHEN TESTED IN THE LABORATORY ENVIRONMENT. INVESTIGATION CONCLUSION: THE DEFECT OF NEEDLE RETRACTION FAILURE AS STATED IN THE EVENT DESCRIPTION COULD NOT BE CONFIRMED WITH THE REPRESENTATIVE UNITS RETURNED FOR EVALUATION AND TESTING. DID THE EVALUATION CONFIRM THE CUSTOMER¿S EXPERIENCE WITH THE BD PRODUCT? NO; THE DEFECT OF NEEDLE RETRACTION FAILURE THAT THE CUSTOMER EXPERIENCED WAS NOT CONFIRMED WITH THE UNITS RECEIVED FOR EVALUATION AND TESTING. WERE WE ABLE TO REPRODUCE THE CUSTOMER'S EXPERIENCE WITH THE BD PRODUCT? NO; REPRODUCTION OF THE FAILURE THAT THE CUSTOMER EXPERIENCED COULD NOT BE ACHIEVED WITH THE EVALUATION AND TESTING PERFORMED ON THE UNITS RECEIVED IN THE LABORATORY ENVIRONMENT. ROOT CAUSE: RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: INDETERMINATE. 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 REPRESENTATIVE UNITS. THE ACTUAL UNIT DESCRIBED IN THE INCIDENT REPORT WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER USE, A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER MALFUNCTIONED AS THE NEEDLE DID NOT RETRACT. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83727 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7220650 30382903814344

    Patients

    Seq Age Sex Outcome Treatment
    1 Other