BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD PICC

    MDR report key: 9885261 · Received March 26, 2020

    Report

    Report Number
    3006260740-2020-01081
    Event Type
    Malfunction
    Date Received
    March 26, 2020
    Report Date
    March 26, 2020
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO PICCS FRACTURED. IT WAS STATED STAFF NOTICED SOME POSITIONAL FUNCTIONING ISSUES AND OCCASIONAL PWO AND FINALLY LEAKAGE AT PICC ENTRY SITE, AFTER REMOVAL PICC SHOWED FRACTURE 2-4CMS ABOVE ENTRY SITE. BOTH PICCS WERE SECURED IN SITU WITH SECURACATH. THIS REPORT ADDRESSES THE FIRST OF THE TWO DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348768 BARD PICC CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS BARD ACCESS SYSTEMS N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1