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: 9547278 · Received January 3, 2020

    Report

    Report Number
    1710034-2019-01388
    Event Type
    Malfunction
    Date Received
    January 3, 2020
    Date of Event
    December 19, 2019
    Report Date
    February 21, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETERS 18GA 1.16IN (1.3 X 30 MM) EXPERIENCED A DAMAGED OR OPEN UNIT PACKAGE/SEAL WHERE STERILITY IS COMPROMISED. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SEALING OF STERILE PACKAGES HAS A SIGNIFICANT BREAKAGE, WITH A PACKAGE THAT IS ALREADY FOUND OPEN BEFORE USE. THE STERILITY OF THE DEVICE IS THEREFORE NO LONGER GUARANTEED.

    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, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8031927. MEDICAL DEVICE EXPIRATION DATE: 2021-01-31. DEVICE MANUFACTURE DATE: 2018-01-31. MEDICAL DEVICE LOT #: 8071875 . MEDICAL DEVICE EXPIRATION DATE: 2021-02-28. DEVICE MANUFACTURE DATE: 2018-03-12.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETERS 18GA 1.16IN (1.3 X 30 MM) EXPERIENCED A DAMAGED OR OPEN UNIT PACKAGE/SEAL WHERE STERILITY IS COMPROMISED. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SEALING OF STERILE PACKAGES HAS A SIGNIFICANT BREAKAGE, WITH A PACKAGE THAT IS ALREADY FOUND OPEN BEFORE USE. THE STERILITY OF THE DEVICE IS THEREFORE NO LONGER GUARANTEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12233 BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 18GA 1.16IN (1.3 X 30 MM) INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other