BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD WINGED SHIELDED IV CATHETER 20GA 1.16IN (1.1 X 30 MM)

    MDR report key: 10089339 · Received May 26, 2020

    Report

    Report Number
    1710034-2020-00331
    Event Type
    Malfunction
    Date Received
    May 26, 2020
    Date of Event
    May 5, 2020
    Report Date
    June 29, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K952861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD RECEIVED 2 UNUSED INSYTE AUTOGUARD 20 GAUGE UNITS FROM LOT 8071737 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNITS AND OBSERVED THAT THE PACKAGES APPEARED TO BEING PEELING NEAR THE END. HOWEVER, THERE APPEARED TO BE TRACES OF ADHESIVE FOUND ON BOTH OF THE PACKAGES INDICATING THAT THE PACKAGES WERE SEALED PROPERLY AT SOME POINT. THE WIDTH OF THE SEAL WAS MEASURED FOR BOTH UNITS AND FOUND TO BE WITHIN PRODUCT SPECIFICATIONS. BASED OFF THE VISUAL INSPECTION THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. IT WAS DETERMINED THAT THERE WAS AN ISSUE WITH A SUPPLIER AND MATERIAL RECEIVED. THIS SUPPLIER HAS BEEN NOTIFIED OF THIS ISSUE AND A NEW SUPPLIER HAS BEEN CHOSEN TO CORRECT THIS FAILURE MODE. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 20GA 1.16IN (1.1 X 30 MM) HAD A DAMAGED PACKAGE WHICH COMPROMISED THE STERILITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A DEPARTMENT AGAIN REPORTS A RUPTURE OF STERILITY ON AUTOGUARD CATHETERS OF REFERENCES 381944 AND 381934. THE PAPER WRAPPING THAT WAS SUPPOSED TO MAINTAIN STERILITY HAS COME OFF IN THE PEEL-OFF AREA."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 20GA 1.16IN (1.1 X 30 MM) HAD A DAMAGED PACKAGE WHICH COMPROMISED THE STERILITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A DEPARTMENT AGAIN REPORTS A RUPTURE OF STERILITY ON AUTOGUARD CATHETERS OF REFERENCES 381944 AND 381934. THE PAPER WRAPPING THAT WAS SUPPOSED TO MAINTAIN STERILITY HAS COME OFF IN THE PEEL-OFF AREA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553548 BD INSYTE AUTOGUARD WINGED SHIELDED IV CATHETER 20GA 1.16IN (1.1 X 30 MM) INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8071737

    Patients

    Seq Age Sex Outcome Treatment
    1 Other