BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD WINGED PNK 20GA X 1.0IN

    MDR report key: 11396521 · Received March 1, 2021

    Report

    Report Number
    1710034-2021-00162
    Event Type
    Malfunction
    Date Received
    March 1, 2021
    Date of Event
    January 13, 2021
    Report Date
    April 2, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903815333
    PMA / PMN Number
    K952861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS RECORD IS BEING CANCELLED AS A DUPLICATE OF MFR REPORT # 1710034-2021-00094 THAT HAS ALREADY BEEN REPORTED FOR MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INSYTE AUTOGUARD WINGED PNK 20GA X 1.0IN HAD A CONNECTIVITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 381533 BATCH NO: 0230741 (X2). IT WAS REPORTED DEFECTIVE IV CATHETERS. VERBATIM: ISSUE # 1. DATE: (B)(6) 2021. REPORT: DEFECTIVE IV CANNULA. BLEB ON CANNULA END AND INJECTION CAP WOULD NOT SCREW ON THE END OF THE CANNULA. REQUIRE NEW IV TO BE PLACED. PATIENT HARM: PATIENT HAD TO BE STUCK AN ADDITIONAL TIME. PRODUCT: BD INSYTE AUTOGUARD WINGED 20GA X1.00 IN. ISSUE # 2: DATE: (B)(6) 2021. REPORT: IV CATHETER CAME OUT OF PACKAGE POKING THROUGH THE PLASTIC CATHETER. PATIENT HARM: NO PATIENT HARM REPORTED. PRODUCT: BD INSYTE AUTOGUARD WINGED 20GA X1.00 IN. ISSUE # 3: DATE: (B)(6) 2021. REPORT: DEFECTIVE IV CANNULA. RN WAS PUTTING IN AN IV AND WHEN PULLING BACK THE CATHETER THE CATHETER PORTION IS MISSING. PATIENT HARM: PATIENT HARM BEING EVALUATED. FURTHER TREATMENT MAY BE NECESSARY. PRODUCT: BD INSYTE AUTOGUARD WINGED 22GA X1.00 IN.

    Additional Manufacturer Narrative · 1

    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 INSYTE AUTOGUARD WINGED PNK 20GA X 1.0IN HAD A CONNECTIVITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 381533 BATCH NO: 0230741 (X2), IT WAS REPORTED DEFECTIVE IV CATHETERS. VERBATIM: ISSUE # 1 DATE: (B)(6) 2021. REPORT: DEFECTIVE IV CANNULA. BLEB ON CANNULA END AND INJECTION CAP WOULD NOT SCREW ON THE END OF THE CANNULA. REQUIRE NEW IV TO BE PLACED. PATIENT HARM: PATIENT HAD TO BE STUCK AN ADDITIONAL TIME. PRODUCT: BD INSYTE AUTOGUARD WINGED 20GA X1.00 IN. ISSUE # 2 DATE: (B)(6) 2021. REPORT: IV CATHETER CAME OUT OF PACKAGE POKING THROUGH THE PLASTIC CATHETER. PATIENT HARM: NO PATIENT HARM REPORTED. PRODUCT: BD INSYTE AUTOGUARD WINGED 20GA X1.00 IN. ISSUE # 3 DATE: (B)(6) 2021. REPORT: DEFECTIVE IV CANNULA. RN WAS PUTTING IN AN IV AND WHEN PULLING BACK THE CATHETER THE CATHETER PORTION IS MISSING. PATIENT HARM: PATIENT HARM BEING EVALUATED. FURTHER TREATMENT MAY BE NECESSARY. PRODUCT: BD INSYTE AUTOGUARD WINGED 22GA X1.00 IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289114 INSYTE AUTOGUARD WINGED PNK 20GA X 1.0IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 0230741 00382903815333

    Patients

    Seq Age Sex Outcome Treatment
    1