BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2FR W/O GW BULK NON

    MDR report key: 11881771 · Received May 25, 2021

    Report

    Report Number
    3006260740-2021-02004
    Event Type
    Malfunction
    Date Received
    May 25, 2021
    Date of Event
    April 30, 2021
    Report Date
    September 10, 2021
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. A LOT HISTORY REVIEW (LHR) OF REDS2221 SHOWED 15 OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER (REDS2221) HAVE BEEN REPORTED FROM THE SAME FACILITY IN BRAZIL.

    Description of Event or Problem · 0

    IT WAS REPORTED TO QUALITY ASSURANCE THAT IT HAS BEEN RECEIVED 14 NOTIFICATIONS, OF CATHETER TOO MUCH MALLEABLE, WITH CONSEQUENCES OF PAIN AND DISCOMFORT TO THE NEWBORN, FAKE PATH IN ITS INSERTION, BEYOND THAT IT WAS REQUIRED PHLEBOTOMY AND ADDITIONAL UMBILICAL CATHETER INSERTION, ADDED TO MULTIPLE HOURS OF NURSE WORK. THIS REPORT ADDRESSES THE SIXTH EVENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO QUALITY ASSURANCE THAT IT HAS BEEN RECEIVED 14 NOTIFICATIONS, OF CATHETER TOO MUCH MALLEABLE, WITH CONSEQUENCES OF PAIN AND DISCOMFORT TO THE NEWBORN, FAKE PATH IN ITS INSERTION, BEYOND THAT IT WAS REQUIRED PHLEBOTOMY AND ADDITIONAL UMBILICAL CATHETER INSERTION, ADDED TO MULTIPLE HOURS OF NURSE WORK. THIS REPORT ADDRESSES THE SIXTH EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771013 2FR W/O GW BULK NON CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS C.R. BARD, INC. (BASD) -3006260740 REDS2221

    Patients

    Seq Age Sex Outcome Treatment
    1 Other