BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD INSYTE AUTOGUARD PNK

    MDR report key: 15996981 · Received December 16, 2022

    Report

    Report Number
    2243072-2022-02168
    Event Type
    Malfunction
    Date Received
    December 16, 2022
    Date of Event
    November 26, 2022
    Report Date
    February 10, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A MODEL OR LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD INSYTE AUTOGUARD PNK THERE WAS VENOUS RUPTURE, WHEN REMOVING THE CATHETER, IT WAS VERIFIED THAT THERE WAS TRANSFIXATION OF THE NEEDLE IN THE CANNON. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: DURING THE PUNCTURE THERE WAS VENOUS RUPTURE, WHEN REMOVING THE CATHETER IT WAS VERIFIED THAT THERE WAS TRANSFIXATION OF THE NEEDLE IN THE CANNON, PERIPHERAL VENOUS CATHETER N 20FR, BD, BATCH 2012529, V 12/30/2024, MATERIAL SAVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD INSYTE AUTOGUARD PNK THERE WAS VENOUS RUPTURE, WHEN REMOVING THE CATHETER, IT WAS VERIFIED THAT THERE WAS TRANSFIXATION OF THE NEEDLE IN THE CANNON. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: DURING THE PUNCTURE THERE WAS VENOUS RUPTURE, WHEN REMOVING THE CATHETER IT WAS VERIFIED THAT THERE WAS TRANSFIXATION OF THE NEEDLE IN THE CANNON, PERIPHERAL VENOUS CATHETER N 20FR, BD, BATCH 2012529, V 12/30/2024, MATERIAL SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1868225 UNSPECIFIED BD INSYTE AUTOGUARD PNK INTRAVASCULAR CATHETER FOZ BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown