BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 24GA 0.75IN (0.7 X 19 MM)

    MDR report key: 9396809 · Received December 2, 2019

    Report

    Report Number
    1710034-2019-01278
    Event Type
    Malfunction
    Date Received
    December 2, 2019
    Date of Event
    November 5, 2019
    Report Date
    December 27, 2019
    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
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLE PROVIDED. BD RECEIVED ONE OPENED UNIT FROM LOT NUMBER 9193539. THE UNIT WAS DISASSEMBLED, AND ALL PARTS WERE PRESENT. THROUGH THE MICROSCOPIC EVALUATION, THE TIP REVEALED WHAT APPEARS TO BE A CRATER AND DAMAGE ALONG THE LENGTH OF THE TUBING. THE DAMAGES SEEN ON THE CATHETER TUBING ARE COMMONLY CAUSED WHEN INSERTING THE NEEDLE INTO THE CATHETER. THE NEEDLE WILL SCRAPE ALONG THE INSIDE OF THE TUBING DAMAGING IT. THIS CAN HAPPEN DURING USE (USER ENVIRONMENT) OR WHEN COMBINING THE CATHETER AND NEEDLE ASSEMBLY (MANUFACTURING). DUE TO THE PACKAGE BEING OPENED AND THE UNIT HAVING BEEN USED, BD CANNOT DETERMINE IF THE DAMAGE TOOK PLACE DURING USE OR THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCE'S ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 24GA 0.75IN (0.7 X 19 MM) INSYTE AUTOGUARD EXPERIENCED CATHETER DIFFICULT ADVANCEMENT/WOULD NOT ADVANCE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 381512. BATCH NO.: 9193539. IT WAS REPORTED THE CATHETER HAD BUBBLED AT THE END WHICH CAUSED THREADING DIFFICULTIES. PER EMAIL: 24G IV 0.75INCH CATHETER CHECKED BEFORE INSERTION. AFTER INSERTION, CATHETER WOULD NOT THREAD. CATHETER REMOVED AND FOUND THAT IT HAD BUBBLED AT THE END. THIS HAS HAPPENED MULTIPLE TIMES WITH THE 24G CATHETERS BOTH 0.75 AND THE .56INCH.

    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 AN UNSPECIFIED NUMBER OF BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 24GA 0.75IN (0.7 X 19 MM) INSYTE AUTOGUARD EXPERIENCED CATHETER DIFFICULT ADVANCEMENT/WOULD NOT ADVANCE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 381512 , BATCH NO.: 9193539. IT WAS REPORTED THE CATHETER HAD BUBBLED AT THE END WHICH CAUSED THREADING DIFFICULTIES. PER EMAIL: 24G IV 0.75INCH CATHETER CHECKED BEFORE INSERTION. AFTER INSERTION, CATHETER WOULD NOT THREAD. CATHETER REMOVED AND FOUND THAT IT HAD BUBBLED AT THE END. THIS HAS HAPPENED MULTIPLE TIMES WITH THE 24G CATHETERS BOTH 0.75 AND THE .56INCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1193722 BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 24GA 0.75IN (0.7 X 19 MM) INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381512 9193539 30382903815129

    Patients

    Seq Age Sex Outcome Treatment
    1 Other