BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE¿ AUTOGUARD¿ IV CATHETER

    MDR report key: 14224617 · Received April 27, 2022

    Report

    Report Number
    1710034-2022-00217
    Event Type
    Injury
    Date Received
    April 27, 2022
    Date of Event
    April 6, 2022
    Report Date
    June 6, 2022
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K201075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES, D9: RETURNED TO MANUFACTURER ON: 12-MAY2022 H6: INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE SAMPLE SUBMITTED FOR EVALUATION. BD RECEIVED ONE SEALED 20G X 1.00IN. INSYTE AUTOGUARD UNIT FROM LOT NUMBER 1222254. A GROSS VISUAL INSPECTION DID NOT FIND ANY DAMAGE TO THE COMPONENTS. THE UNIT WAS FUNCTIONALLY TESTED FOR RETRACTION. THE UNIT SUCCESSFULLY RETRACTED. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE RETURNED UNIT PROVIDED FOR EVALUATION MET AND PERFORMED PER THE REQUIRED MANUFACTURING SPECIFICATIONS. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE FAILURE STATED IN THE REPORT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ IV CATHETER'S SAFETY MECHANISM FAILED TO RETRACT THE NEEDLE AND THE NURSE PRICKED THEIR FINGER ON IT, REQUIRING BLOOD TESTING PER PROTOCOL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "DURING THE INSERTION OF A CATHETER, WHEN REMOVING THE MANDREL, ONE OF OUR NURSES TRIED TO ACTIVATE THE CATHETER SAFETY. HOWEVER, THE MECHANISM DID NOT WORK, THE CHUCK DID NOT RETRACT. THE PATIENT THOUGHT THE PROCEDURE WAS OVER, MOVED AND THE NURSE PRICKED HER FINGER WITH THE CATHETER."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ IV CATHETER'S SAFETY MECHANISM FAILED TO RETRACT THE NEEDLE AND THE NURSE PRICKED THEIR FINGER ON IT, REQUIRING BLOOD TESTING PER PROTOCOL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "DURING THE INSERTION OF A CATHETER, WHEN REMOVING THE MANDREL, ONE OF OUR NURSES TRIED TO ACTIVATE THE THE CATHETER SAFETY. HOWEVER, THE MECHANISM DID NOT WORK, THE CHUCK DID NOT RETRACT. THE PATIENT THOUGHT THE PROCEDURE WAS OVER, MOVED AND THE NURSE PRICKED HER FINGER WITH THE CATHETER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912798 BD INSYTE¿ AUTOGUARD¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 1222254

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention