BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE-N AUTOGUARD WINGED YEL 24GAX.56IN

    MDR report key: 10557370 · Received September 18, 2020

    Report

    Report Number
    1710034-2020-00594
    Event Type
    Malfunction
    Date Received
    September 18, 2020
    Date of Event
    August 30, 2020
    Report Date
    September 28, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903815112
    PMA / PMN Number
    K952861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLE, BATCH, OR LOT CODE WAS PROVIDED. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INSYTE-N AUTOGUARD WINGED YEL 24GAX.56IN CATHETER WAS NOT WORKING WELL. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: (B)(6). IT WAS REPORTED 24 GAUGE IV CATHETERS NOT WORKING WELL. UNABLE TO OBTAIN IV ACCESS ON A NEW 34 WEEK ADMIT. VERBATIM: 24 GAUGE IV CATHETERS NOT WORKING WELL. UNABLE TO OBTAIN IV ACCESS ON A NEW 34 WEEK ADMIT. ATTEMPTED MULTIPLE TIMES, INCLUDING AN ATTEMPT BY NNP, BEFORE HAVING TO PUT A UVC IN. PLEASE REVIEW QRR REPORT FOR QRR'S ENTERED FOR FAULTY IV CATHETERS IN NICU. THE NEW ANGIOCATHS ARE NOT WORKING WELL.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. (B)(6) HAS BEEN USED AS A DEFAULT. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INSYTE-N AUTOGUARD WINGED YEL 24GAX.56IN CATHETER WAS NOT WORKING WELL. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 381511 BATCH, NO: UNKNOWN. IT WAS REPORTED 24 GAUGE IV CATHETERS NOT WORKING WELL. UNABLE TO OBTAIN IV ACCESS ON A NEW 34 WEEK ADMIT. VERBATIM: 24 GAUGE IV CATHETERS NOT WORKING WELL. UNABLE TO OBTAIN IV ACCESS ON A NEW 34 WEEK ADMIT. ATTEMPTED MULTIPLE TIMES, INCLUDING AN ATTEMPT BY NNP, BEFORE HAVING TO PUT A UVC IN. PLEASE REVIEW QRR REPORT FOR QRR'S ENTERED FOR FAULTY IV CATHETERS IN NICU. THE NEW ANGIOCATHS ARE NOT WORKING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022002 INSYTE-N AUTOGUARD WINGED YEL 24GAX.56IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381511 UNKNOWN 30382903815112

    Patients

    Seq Age Sex Outcome Treatment
    1 Other