BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 10457891 · Received August 26, 2020

    Report

    Report Number
    1710034-2020-00540
    Event Type
    Malfunction
    Date Received
    August 26, 2020
    Date of Event
    August 10, 2020
    Report Date
    August 17, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814122
    PMA / PMN Number
    K952861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: OBSERVATIONS AND TESTING COULD NOT BE PERFORMED IN THE ABSENCE OF A SAMPLE. THE DHR FOR LOT 0080382 HAS BEEN REVIEWED. THIS LOT WAS BUILT AND PACKAGED ON AFA LINE 13 FROM 26MAR2020 THROUGH 31MAR2020 FOR A QUANTITY OF 369610 UNITS. NO RELATED QUALITY ISSUES OR PROCESS DEVIATIONS WERE FOUND. PEURA RM5835, REV 18, VERSION Q HAS BEEN REVIEWED. THIS TYPE OF FAILURE HAS BEEN INCLUDED AND ASSESSED FOR RISK ON MULTIPLE PAGES, AND IT IS IMPOSSIBLE TO NARROW IT DOWN WITHOUT THE SAMPLE. INVESTIGATION CONCLUSION: THE DEFECT NEEDLE RETRACTION FAILURE COULD NOT BE REFUTED NOR CONFIRMED IN THE ABSENCE OF A SAMPLE. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 3RD RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF NEEDLE RETRACTION FAILURE WITH LOT #0080382 REGARDING ITEM #381412. RELATED PRS 1702059 ¿ INVESTIGATION PENDING AND 1751117 ¿ INVESTIGATION PENDING. ROOT CAUSE DESCRIPTION: THE ROOT CAUSE CANNOT BE DETERMINED FOR AN UNCONFIRMED DEFECT. RATIONALE: CUSTOMER COMPLAINT TRENDS ARE EVALUATED ON A MONTHLY BASIS, HOWEVER THE NEED FOR A FORMAL CORRECTIVE ACTION CANNOT BE DETERMINED IN THE ABSENCE OF THE ROOT CAUSE. RISK TO THE END USER IS ESTABLISHED BASED ON OCCURRENCE AND SEVERITY OF THE DEFECT AS RELATED TO A SPECIFIC FAILURE MODE IN THE MANUFACTURING PROCESS AND THE EFFECTS OF THAT FAILURE. THE RISK COULD NOT BE EVALUATED FOR THE UNCONFIRMED DEFECT IN THE ABSENCE OF THE ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER NEEDLE DIDN'T FULLY RETRACT DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "INSYTE AUTOGUARD YEL 24GA X .75IN WOULDN'T FULLY RETRACT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922441 BD INSYTE AUTOGUARD SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381412 0080382 30382903814122

    Patients

    Seq Age Sex Outcome Treatment
    1 Other