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: 10687846 · Received October 15, 2020

    Report

    Report Number
    1710034-2020-00661
    Event Type
    Malfunction
    Date Received
    October 15, 2020
    Date of Event
    September 23, 2020
    Report Date
    December 22, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903815129
    PMA / PMN Number
    K952861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE SAMPLE SUBMITTED FOR EVALUATION. BD RECEIVED ONE UNIT WITHIN OPENED PACKAGING FROM REF 381512, LOT 0052056. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. DURING THE VISUAL EXAMINATION IT WAS OBSERVED THAT THERE WAS BLACK FOREIGN MATTER INSIDE THE NEEDLE COVER, ON THE NOSE OF THE WINGED ADAPTER, ON THE BOTTOM OF THE WINGS, ALONG THE THE FULL LENGTH OF THE CATHETER TUBING, AND IN THE BEVEL OF THE CANNULA. THE REPORTED ISSUE WAS CONFIRMED. SPECTRAL ANALYSIS WAS PERFORMED TO IDENTIFY THE FOREIGN MATERIAL. THE MATERIAL WAS FOUND TO LIKELY BE NYLON 11. NYLON CAN BE FOUND IN THE FILM USED FOR PACKAGING. OVER TIME THIS FILM CAN ACCUMULATE ON THE HEATING PLATES USED TO SEAL THE PACKAGING. PREVENTATIVE MAINTENANCE, CLEANING, AND INSPECTION OF THE ZONE WERE PERFORMED AS SCHEDULED. ALTHOUGH THE REPORTED ISSUE WAS CONFIRMED, BD WAS UNABLE TO DETERMINE A DEFINITE ROOT CAUSE FOR THE NYLON MATERIAL FOUND ON THE CATHETER TUBING AND ADAPTER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 24GA 0.75IN (0.7 X 19 MM) EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 381512, BATCH NO: 0052056. VERBATIM: DIRTY NEEDLES.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 24GA 0.75IN (0.7 X 19 MM) EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 381512, BATCH NO: 0052056. VERBATIM: DIRTY NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152591 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 0052056 30382903815129

    Patients

    Seq Age Sex Outcome Treatment
    1 Other