BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6699046 · Received July 10, 2017

    Report

    Report Number
    1710034-2017-00105
    Event Type
    Malfunction
    Date Received
    July 10, 2017
    Date of Event
    June 19, 2017
    Report Date
    August 22, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    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).

    Additional Manufacturer Narrative · 1

    ONE USED SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL/MICROSCOPIC INSPECTION REVEALED THAT THE UNIT CONSISTED OF NEEDLE/SAFETY BARREL ASSEMBLY. THE NEEDLE WAS NOT RETRACTED INTO THE SAFETY BARREL AND THE BUTTON WAS NOT DEPRESSED. CURED ADHESIVE WAS OBSERVED ACROSS THE TOP OF THE SAFETY ACTIVATION BUTTON AND IN THE CREVICE BETWEEN THE BUTTON AND THE GRIP. SIMULATED USE TEST WAS PERFORMED BY PRESSING THE SAFETY ACTIVATION BUTTON AND THE NEEDLE DID NOT RETRACT INTO THE SAFETY BARREL. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 7062526. CONCLUSION: THE ROOT CAUSE FOR THIS INCIDENT HAS BEEN DETERMINED TO BE A MANUFACTURING DEFICIENCY. THE CURED ADHESIVE OBSERVED ON THE OUTER WALL OF THE HUB WAS PHYSICAL EVIDENCE TO CONFIRM AND SUPPORT THE MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECT. ALTHOUGH THIS COMPLAINT WAS NOT LINKED TO A QN, THERE IS CURRENTLY A QN CORRECTIVE ACTION FOR VERIFICATION OF A SECURE NOZZLE ACM-314. NO FURTHER FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE OF A 20 G X 1.16 IN. BD INSYTE AUTOGUARD SHIELDED IV CATHETER FAILED TO RETRACT AFTER A NURSE PRESSED THE SAFETY ACTIVATION BUTTON. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478394 20 G X 1.16 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7062526

    Patients

    Seq Age Sex Outcome Treatment
    1 Other