BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20 GAUGE POWERGLIDE PRO MIDLINE CATHETER 8CM BASIC KIT

    MDR report key: 11713048 · Received April 23, 2021

    Report

    Report Number
    3006260740-2021-01471
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    December 31, 2020
    Report Date
    April 16, 2021
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    FOZ
    PMA / PMN Number
    K162377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF REDV3445 SHOWED TWO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER HAVE BEEN REPORTED FROM THE SAME FACILITY IN (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2020, WHEN PLACING THE MIDLINE PERIPHERAL CATHETER IN THE RECOVERY ROOM, THE END OF THE GUIDE BENDS. A SECOND DEVICE IS USED AND THEN A THIRD, WITHOUT SUCCESS. THE CONSEQUENCES FOR THE PATIENT ARE MARKED BY AN EXTENSION OF THE DURATION OF THE INSTALLATION OF THE MIDLINE AND THE ASSOCIATED PAIN. IT WAS REPORTED THIS EVENT OCCURRED WITH THREE DEVICES. THIS REPORT ADDRESSES THE THIRD DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609865 20 GAUGE POWERGLIDE PRO MIDLINE CATHETER 8CM BASIC KIT CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ C.R. BARD, INC. (BASD) -3006260740 REDV3445

    Patients

    Seq Age Sex Outcome Treatment
    1 Other