BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER

    MDR report key: 10423674 · Received August 18, 2020

    Report

    Report Number
    1710034-2020-00526
    Event Type
    Malfunction
    Date Received
    August 18, 2020
    Date of Event
    July 27, 2020
    Report Date
    September 18, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825234
    PMA / PMN Number
    K110443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 8/20/2020. H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE REPRESENTATIVE SAMPLES AND PHOTOGRAPH SUBMITTED FOR EVALUATION. BD RECEIVED FIVE UNUSED REPRESENTATIVE INSYTE AUTOGUARD BC 22GA UNITS IN SEALED PACKAGING FROM MATERIAL NUMBER 382523, LOT NUMBER 0063779. IN ADDITION, ONE PHOTOGRAPH WAS RECEIVED WHICH DISPLAYED AN OPENED PACKAGE AND A USED UNIT. NO CATHETER-ADAPTER ASSEMBLY WAS PRESENT. THE WHITE BUTTON IS DEPRESSED ON THE PHOTOGRAPH SAMPLE, BUT THE NEEDLE IS NOT RETRACTED. THE PHOTOGRAPH QUALITY IS NOT SUFFICIENT FOR A MEANINGFUL EXAMINATION OF THE POSSIBLE UNIT DEFECTS THAT MAY CAUSE RETRACTION FAILURE. A VISUAL/MICROSCOPIC EVALUATION WAS PERFORMED ON THE REPRESENTATIVE UNITS. THERE WAS NO MECHANICAL/PHYSICAL DAMAGE TO ANY OF THE COMPONENTS (SPRING, NEEDLE, HUB, GRIP) OR EVIDENCE OF ADHESIVE ON THE BUTTON OR HUB. A FUNCTIONAL TEST WAS PERFORMED WHERE ALL RETRACTIONS WERE SUCCESSFUL AS THERE WERE NO DELAYED REACTIONS OBSERVED. THE RETURNED REPRESENTATIVE 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 THE REPORT. ALTHOUGH THE REPORTED ISSUE WAS CONFIRMED FROM THE REVIEW OF THE PHOTOGRAPH, THE PHOTOGRAPH PROVIDED FOR THIS INCIDENT DID NOT PRESENT SUFFICIENT EVIDENCE TO IDENTIFY A DEFINITE ROOT CAUSE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER NEEDLE DID NOT RETRACT WHEN THE BUTTON WAS PRESSED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " FOLLOWING AN ATTEMPT TO INSERT A PERIPHERAL IV INTO A VEIN IN THE PATIENTS RIGHT HAND, I PUSHED THE SAFETY FEATURE BUTTON THAT SHOULD HAVE INSTANTLY RETRACTED THE NEEDLE-IT DID NOT RETRACT. THANKFULLY, NEITHER THE PATIENT, NOR I WERE INJURED."

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER NEEDLE DID NOT RETRACT WHEN THE BUTTON WAS PRESSED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FOLLOWING AN ATTEMPT TO INSERT A PERIPHERAL IV INTO A VEIN IN THE PATIENTS RIGHT HAND, I PUSHED THE SAFETY FEATURE BUTTON THAT SHOULD HAVE INSTANTLY RETRACTED THE NEEDLE, IT DID NOT RETRACT. THANKFULLY, NEITHER THE PATIENT, NOR I WERE INJURED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883039 BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 382523 0063779 30382903825234

    Patients

    Seq Age Sex Outcome Treatment
    1 Other