BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 10639233 · Received October 6, 2020

    Report

    Report Number
    1710034-2020-00647
    Event Type
    Malfunction
    Date Received
    October 6, 2020
    Date of Event
    September 10, 2020
    Report Date
    November 4, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO CORRECTED INFORMATION: D.10. DEVICE AVAILABLE FOR EVALUATION? NO. H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETERS' NEEDLE'S FAILED TO FULLY RETRACT DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 5TH OF 5 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE NEEDLE DID NOT FULLY RETRACT AFTER STARTING AN IV ON A PATIENT." "THESE EVENTS HAVE HAPPENED MULTIPLE TIMES TO MYSELF. (B)(6)2020 X1: (B)(6)20/20 X2:(B)(6)2020 X2. AND THEN 1 TIME FOR *OMITTED*. LOT # 0080382"

    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 2 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETERS' NEEDLE'S FAILED TO FULLY RETRACT DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 5TH OF 5 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THAT THE NEEDLE DID NOT FULLY RETRACT AFTER STARTING AN IV ON A PATIENT." "THESE EVENTS HAVE HAPPENED MULTIPLE TIMES TO MYSELF. (B)(6) 2020, AND THEN 1 TIME FOR *OMITTED*. LOT # 0080382"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097536 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