BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICC SOLO

    MDR report key: 23129102 · Received September 23, 2025

    Report

    Report Number
    3006260740-2025-07151
    Event Type
    Malfunction
    Date Received
    September 23, 2025
    Date of Event
    July 23, 2025
    Report Date
    October 4, 2025
    Manufacturer
    BARD REYNOSA S.A. DE C.V. -9617592
    Product Code
    LJS
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MEDWATCH REPORT WAS SUBMITTED, UPON FURTHER REVIEW IT WAS FOUND THAT THIS MEDWATCH REPORT 3006260740-2025-07151 IS A DUPLICATE FILE AND HAS BEEN VOIDED. THE ORIGINAL EVENT WAS SUBMITTED ON MEDWATCH REPORT 3006260740-2025-05725.

    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. EACH EVENT REPORTED TO BD IS EVALUATED AND INVESTIGATED IN ACCORDANCE WITH OUR COMPLAINT INVESTIGATION PROCEDURES. THE INVESTIGATION PROCESS INCLUDES, BUT IS NOT LIMITED TO, EVALUATION OF THE EVENT DETAILS PROVIDED BY THE COMPLAINT FACILITY, A REVIEW OF COMPLAINT HISTORY, MANUFACTURING RECORDS AND RISK DOCUMENT WHERE APPLICABLE, AND AN EVALUATION OF THE SUBJECT DEVICE WHEN AVAILABLE TO IDENTIFY POTENTIAL CONTRIBUTING FACTORS. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED, PATIENT ATTENDED UNIT FOR CHEMOTHERAPY. ON ADMINISTERING 2ML OF A 10ML PRE SODIUM CHLORIDE FLUSH PATIENT REPORTED PAIN SURROUNDING PICC ENTRANCE SITE TO STAFF NURSE. PICC PLACER NOTIFIED AND ASSESSED PICC. DRESSING REMOVED AND DURING FURTHER 2ML SODIUM CHLORIDE FLUSH SKIN NOTED TO BE SWELLING ABOVE PICC SIT. FRACTURE SUSPECTED, PICC LINE REMOVED AND FRACTURE CONFIRMED BETWEEN MARKINGS 9 AND 10. NOTED PATIENT ATTENDED ASSESSMENT ON MONDAY FOR PICC ASSESSMENT FOLLOWING HELPLINE CALL TO REPORT ARM SWELLING AND PAIN AT PICC SITE BY DN. REVIEWED BY DR AND DISCHARGED HOME. PICC LINE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733181 POWERPICC SOLO PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LJS BARD REYNOSA S.A. DE C.V. -9617592 N/A REJV3042

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other