BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 18GA 1.16IN (1.3 X 30 MM)

    MDR report key: 9806246 · Received March 9, 2020

    Report

    Report Number
    1710034-2020-00152
    Event Type
    Malfunction
    Date Received
    March 9, 2020
    Date of Event
    February 15, 2020
    Report Date
    April 21, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903815440
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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¿ WINGED SHIELDED IV CATHETER 18GA 1.16IN (1.3 X 30 MM) EXPERIENCED A NEEDLE THAT WOULD NOT RETRACT. PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 381544 BATCH NO.: 9113561 PER EMAIL: EMPLOYEE HARED WITH ME THAT A PSN (PATIENT SAFETY NETWORK) WAS LOGGED ON AN INSYTE CATHETER THAT WOULD NOT RETRACT THE NEEDLE. WHILE I AM ONLY AWARE OF THIS ONE PSN, THERE IS APPARENTLY ANOTHER INCIDENT REPORTED BY A DIFFERENT NURSE. I BELIEVE BOTH OF THESE INCIDENTS HAVE OCCURRED AT THE WOMEN'S AND CHILDREN'S USER FACILITY. THE MATERIAL # IS 381544 AND THE LOT NUMBER IS 9113561 BOTH INCIDENTS WERE 18GA. RIGHT NOW THEY ARE MONITORING TO OBSERVE ANY TRENDS.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 18GA 1.16IN (1.3 X 30 MM) EXPERIENCED A NEEDLE THAT WOULD NOT RETRACT. PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 381544, BATCH NO.: 9113561. PER EMAIL: EMPLOYEE HARED WITH ME THAT A PSN (PATIENT SAFETY NETWORK) WAS LOGGED ON AN INSYTE CATHETER THAT WOULD NOT RETRACT THE NEEDLE. WHILE I AM ONLY AWARE OF THIS ONE PSN, THERE IS APPARENTLY ANOTHER INCIDENT REPORTED BY A DIFFERENT NURSE. I BELIEVE BOTH OF THESE INCIDENTS HAVE OCCURRED AT THE WOMEN'S AND CHILDREN'S USER FACILITY. THE MATERIAL # IS 381544 AND THE LOT NUMBER IS 9113561 BOTH INCIDENTS WERE 18GA. RIGHT NOW THEY ARE MONITORING TO OBSERVE ANY TRENDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267738 BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 18GA 1.16IN (1.3 X 30 MM) INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381544 9113561 30382903815440

    Patients

    Seq Age Sex Outcome Treatment
    1 Other