BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 9438738 · Received December 9, 2019

    Report

    Report Number
    1710034-2019-01309
    Event Type
    Malfunction
    Date Received
    December 9, 2019
    Date of Event
    November 19, 2019
    Report Date
    January 14, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903815129
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    MATERIAL NO.: 381512 BATCH NO.: 9193539 IT WAS REPORTED THAT DURING USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THE CATHETER PULLS OFF THE NEEDLE WITH THE LID. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ARE HAVING A PROBLEM WITH THE BD 24G ANGIO CATH, WHEN YOU PULL THE LID OFF THE CATHETER PULLS OFF THE NEEDLE WITH THE LID. THIS IS HAPPENING EVERYDAY AND WITH ALMOST EVERY CATHETER. THIS CAUSES US TO TRY AND PUT THE CATHETER BACK ON THE NEEDLE WITH THE RISK OF THE CATHETER SPLITTING. THIS HAS BEEN GOING ON FOR SEVERAL WEEKS. THE LOT NUMBER FOR TODAY IS 9193539 VERY FRUSTRATING AND CAUSES US TO STICK THE PATIENT MORE THAN ONCE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO.: 381512, BATCH NO.: 9193539. IT WAS REPORTED THAT DURING USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THE CATHETER PULLS OFF THE NEEDLE WITH THE LID. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ARE HAVING A PROBLEM WITH THE BD 24G ANGIO CATH, WHEN YOU PULL THE LID OFF THE CATHETER PULLS OFF THE NEEDLE WITH THE LID. THIS IS HAPPENING EVERYDAY AND WITH ALMOST EVERY CATHETER. THIS CAUSES US TO TRY AND PUT THE CATHETER BACK ON THE NEEDLE WITH THE RISK OF THE CATHETER SPLITTING. THIS HAS BEEN GOING ON FOR SEVERAL WEEKS. THE LOT NUMBER FOR TODAY IS 9193539 VERY FRUSTRATING AND CAUSES US TO STICK THE PATIENT MORE THAN ONCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1236970 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381512 9193539 30382903815129

    Patients

    Seq Age Sex Outcome Treatment
    1 Other