BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20 G X 1.16 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 6566764 · Received May 15, 2017

    Report

    Report Number
    1710034-2017-00084
    Event Type
    Malfunction
    Date Received
    May 15, 2017
    Date of Event
    April 26, 2017
    Report Date
    July 7, 2017
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: ONE USED SAMPLE, 225 UNUSED SAMPLES, AND EIGHT PHOTOS WERE RETURNED FOR EVALUATION. THE FOLLOWING INVESTIGATION WAS PERFORMED: USED SAMPLE: A VISUAL/MICROSCOPIC INSPECTION REVEALED TRACES OF DRIED MEDIA IN THE UNIT. THE UNIT CONSISTED OF THE NEEDLE/HUB ASSEMBLY AND SAFETY BARREL. THE PROTECTIVE NEEDLE COVER WAS INTACT. THE SAFETY ACTIVATION BUTTON WAS COMPLETELY DEPRESSED, THE NEEDLE WAS NOT RETRACTED, AND THE SPRING WAS BOUND. NO ADDITIONAL ANOMALIES OR MECHANICAL/PHYSICAL DAMAGE WAS OBSERVED TO THE NEEDLE, GRIP, OR NEEDLE/HUB THAT WOULD CONTRIBUTE TO THE FAILURE. A SIMULATED USE TEST WAS PERFORMED BY RESETTING THE NEEDLE AND SAFETY ACTIVATION BUTTON TO THE OUT POSITION. THE BUTTON WAS PRESSED AND THE NEEDLE DID NOT RETRACT. UNUSED SAMPLES: ALL UNITS WERE IN SEALED PACKAGES AND ALL COMPONENTS WERE PRESENT AND INTACT. A RANDOM SAMPLING OF 76 UNITS WERE EVALUATED. A VISUAL/MICROSCOPIC INSPECTION REVEALED NO ANOMALIES OR MECHANICAL/PHYSICAL DAMAGE TO THE NEEDLE, GRIP, SPRING OR NEEDLE/HUB THAT WOULD CONTRIBUTE TO THE FAILURE. A SIMULATED USE TEST WAS PERFORMED BY PRESSING THE SAFETY ACTIVATION BUTTON FOR NEEDLE RETRACTION. RETRACTION WAS SUCCESSFUL ON ALL UNITS WITH NO DRAG OR RESISTANCE. PHOTOS: A PHOTO INSPECTION REVEALED A UNIT CONSISTING OF THE NEEDLE/HUB ASSEMBLY BARREL WITH TRACES OF MEDIA. THE NEEDLE WAS IN THE OUT POSITION WITH THE BUTTON COMPLETELY DEPRESSED AND SPRING WIRE BOUND, INDICATING RETRACTION FAILURE DHR REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6243743. CONCLUSION: THE ROOT CAUSE FOR THIS INCIDENT HAS BEEN DETERMINED TO BE A MANUFACTURING DEFICIENCY. ALTHOUGH EVALUATION AND TESTING OF THE RETURNED UNUSED REPRESENTATIVE UNITS REVEALED NO DAMAGE AND RETRACTED SUCCESSFULLY MEETING SPECIFICATIONS, THE USED UNIT AND THE PHOTOS PROVIDED FOR THIS INCIDENT REVEALED EVIDENCE OF NEEDLE RETRACTION FAILURE WITH BOUND SPRING. A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME, HOWEVER, MANUFACTURING WAS NOTIFIED OF THIS INCIDENT AND THE FINDINGS AND CUSTOMER COMPLAINT TRENDS WILL CONTINUE TO BE EVALUATED ON A MONTHLY BASIS. IF THE TREND OF A SPECIFIC TYPE OF COMPLAINT WARRANTS A FORMAL CORRECTIVE ACTION, RESOURCES WILL BE ASSIGNED AT THAT TIME.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 A NEEDLE OF A 20 G X 1.16 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER DID NOT RETRACT AFTER THE SAFETY ACTIVATION BUTTON WAS PRESSED. THE REPORTING HOSPITAL ALSO STATED THAT THIS TYPE OF INCIDENT OCCURS FREQUENTLY. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349443 20 G X 1.16 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 6243743

    Patients

    Seq Age Sex Outcome Treatment
    1 Other