BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22GA

    MDR report key: 16345306 · Received February 10, 2023

    Report

    Report Number
    1710034-2023-00091
    Event Type
    Malfunction
    Date Received
    February 10, 2023
    Date of Event
    January 18, 2023
    Report Date
    April 4, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814237
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 27-FEB-2023 . H6: INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE REPRESENTATIVE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED (3) 2243842 FOR THE INVESTIGATION OF THIS COMPLAINT. A GROSS VISUAL INSPECTION SHOWS THAT ALL THE UNITS WERE SEALED IN PACKAGING WITH NO APPARENT PHYSICAL DAMAGE. THE UNITS WERE TAKEN OUT OF THE PACKAGING, TIP ADHESION WAS PERFORMED AND THE SAFETY BUTTON WAS ACTIVATED. UPON ACTIVATION, THE NEEDLE RETRACTED SAFELY IN THE SAFETY SHIELD WITHOUT ANY RESISTANCE. THERE WAS NO RESISTANCE NOR OBSERVED DEFECT OF THE SAFETY BUTTON. THE RETURNED UNITS 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 FAILURES STATED IN YOUR REPORT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. HOWEVER, A TREND HAS BEEN IDENTIFIED FOR THE REPORTED FAILURE AND CORRECTIVE ACTIONS HAVE BEEN INITIATED TO INVESTIGATE THIS TYPE OF INCIDENT AND IDENTITY THE ROOT CAUSE.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22GA THE NEEDLE WOULD NOT RETRACT. THIS OCCURRED 3 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE TESTED THE NEEDLE RETRACT BUTTON ON 3 22 GA X 1IN ANGIOCATH IV NEEDLES. IN ALL 3, THE NEEDLE DID NOT RETRACT WHEN THE BUTTON WAS PUSHED AND THE BUTTON STAYED DEPRESSED. IF WE SLID THE CATHETER OFF THE NEEDLE AND PUSHED THE BUTTON, THE NEEDLE WOULD RETRACT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22GA THE NEEDLE WOULD NOT RETRACT. THIS OCCURRED 3 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE TESTED THE NEEDLE RETRACT BUTTON ON 3 22 GA X 1IN ANGIOCATH IV NEEDLES. IN ALL 3, THE NEEDLE DID NOT RETRACT WHEN THE BUTTON WAS PUSHED AND THE BUTTON STAYED DEPRESSED. IF WE SLID THE CATHETER OFF THE NEEDLE AND PUSHED THE BUTTON, THE NEEDLE WOULD RETRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163119 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22GA INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381423 2243842 00382903814237

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown