BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 10463647 · Received August 27, 2020

    Report

    Report Number
    1710034-2020-00543
    Event Type
    Malfunction
    Date Received
    August 27, 2020
    Date of Event
    August 11, 2020
    Report Date
    August 14, 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: NO PHOTOS OR PHYSICAL PRODUCT TO RETURN. THE DHR FOR LOT 0080382 HAS BEEN REVIEWED. (B)(4). NO RELATED QUALITY ISSUES OR PROCESS DEVIATIONS WERE FOUND. THE DEFECT NEEDLE RETRACTION FAILURE COULD NOT BE REFUTED NOR CONFIRMED IN THE ABSENCE OF A SAMPLE. INVESTIGATION CONCLUSION: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 4TH RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF NEEDLE RETRACTION FAILURE WITH LOT #0080382 REGARDING ITEM #381412. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER NEEDLE DOES NOT FULLY RETRACT. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 381412, BATCH NO: 0080382. IT WAS REPORTED THAT THE NEEDLE DOES NOT FULLY RETRACT. PR 3 OF 3: THIS PR IS FOR DATE OF EVENT (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928217 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