BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 7566444 · Received June 4, 2018

    Report

    Report Number
    1710034-2018-00264
    Event Type
    Malfunction
    Date Received
    June 4, 2018
    Date of Event
    May 16, 2018
    Report Date
    September 14, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DEVICE/BATCH HISTORY RECORD REVIEW: THE UNITS WERE MANUFACTURED ON AFA LINE 1 FROM 5JUL17 THROUGH 10JUL17 AND PACKAGED ON LINE 9 FROM 14JUL17 THROUGH 17JUL17. ALL CHALLENGES, SET UP AND IN PROCESS INSPECTIONS WERE PERFORMED AND PASSED PER SPECIFICATIONS. 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 2 UNUSED 20GA IAG UNITS WITHIN SEALED PACKAGES FROM LOT NUMBER 7180630. ALL COMPONENTS WERE PRESENT AND INTACT. VISUAL/MICROSCOPIC EXAMINATION: THE UNITS REVEALED NO MECHANICAL/PHYSICAL DAMAGE TO ANY OF THE COMPONENTS. THERE WERE NO BENDS, HOLES, SPLITS, KINKS OR WRINKLES IN THE TUBING OF THE UNITS. LIE DISTANCE: THE UNITS WERE WITHIN THE ACCEPTABLE RANGE OF 0.001 - 0.023. FLASHBACK: THE FLASHBACK WAS PERFORMED TO RE-CREATE THE CUSTOMER EXPERIENCE. THE CATHETER SUCCESSFULLY WENT INTO THE ARTIFICIAL VEIN, THE WHITE BUTTON WAS PUSHED AND A 10ML LUER SYRINGE WAS CONNECTED TO THE END OF THE LUER ADAPTER. THE BLOOD DID NOT BACK OUT. INVESTIGATION CONCLUSION: ROOT CAUSE; RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: INDETERMINATE: COMMENT: THERE WAS NO PHYSICAL OR MECHANICAL EVIDENCE TO CONFIRM OR SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE REPORTED DEFECT. THE UNITS TESTED DID NOT DISPLAY ANY ADVERSE CHARACTERISTICS THAT WOULD CONTRIBUTE TO THE DEFECT THE CUSTOMER EXPERIENCED. THE ACTUAL UNIT WAS NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER; DEVICE SINGLE USE?: NO; DEVICE RETURNED TO MANUFACTURE: YES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BLOOD LEAKED WHEN USING A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BLOOD LEAKED WHEN USING A BD INSYTE AUTOGUARD SHIELDED IV CATHETER. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLOOD LEAKED WHEN USING A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408649 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7180630 30382903814344

    Patients

    Seq Age Sex Outcome Treatment
    1 Other