BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICC SOLO2

    MDR report key: 22303164 · Received June 20, 2025

    Report

    Report Number
    3006260740-2025-04127
    Event Type
    Malfunction
    Date Received
    June 20, 2025
    Date of Event
    May 28, 2025
    Report Date
    August 6, 2025
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    UDI-DI
    00801741139079
    PMA / PMN Number
    K072230
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. 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.

    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. THE COMPLAINT OF A LEAK WAS CONFIRMED. THE PRODUCT RETURNED FOR EVALUATION WAS ONE 4 FR SINGLE LUMEN POWERPICC SOLO CATHETER. THE INVESTIGATION FINDINGS ARE CONSISTENT WITH DAMAGE ACCUMULATED THROUGH FLEXURAL FATIGUE. FLEXURAL FATIGUE MAY OCCUR DUE TO CYCLIC KINKING OF THE CATHETER TUBE IN WHICH PHYSIOLOGICAL, PLACEMENT, USAGE, AND MECHANICAL FACTORS MAY GRADUALLY FORM A CRACK(S) IN THE CATHETER. THE RETURNED PRODUCT SAMPLE WAS EVALUATED, AND A SPLIT WAS OBSERVED AT THE 7 CM DEPTH MARKER. A SECTION OF CATHETER WAS FOUND FLATTENED BETWEEN 2.5 CM AND 4.5 CM. THE CATHETER SPLIT CONTAINED PHYSICAL FEATURES ASSOCIATED WITH MATERIAL FATIGUE, AND THE CHARACTERISTICS OBSERVED WHICH SUPPORTED THIS TYPE OF FAILURE INCLUDED: ¿ DAMAGE WHICH WAS CIRCUMFERENTIALLY ALIGNED. ¿ FRACTURE EDGES WHICH WERE ROUNDED AND POLISHED DUE TO REPEATED MATERIAL WEAR ¿ 'C' SHAPED IMPRESSIONS LEADING INTO THE FRACTURE SITE WHICH ARE CONSISTENT WITH MATERIAL BUCKLING DUE TO MOVEMENT WHICH CAUSED THE FRACTURE EDGES TO BE PRESSED TOGETHER. ¿ OVERALL ELLIPTICAL SHAPE TO THE FRACTURE CROSS-SECTION (A RESULT OF REPEATED KINKING OF THE TUBING). REPETITIVE KINKING OF THE INDWELLING CATHETER APPEARS TO HAVE CONTRIBUTED TO THE OBSERVED LEAK; HOWEVER, THE SPECIFIC CIRCUMSTANCES SURROUNDING HOW KINKING DEVELOPED INTO A FRACTURE WITHIN THE CATHETER TUBING WERE ULTIMATELY UNKNOWN. THIS COMPLAINT WILL BE RECORDED FOR FUTURE TRENDING AND MONITORING PURPOSES.

    Description of Event or Problem · 0

    IT WAS REPORTED, DISTRICT NURSE HAD CONTACT SACT HELPLINE TO REPORT PICC LINE FRACTURE WHEN ATTENDING TO REDNESS AND FLUSH LINE. APPEARED TO BE LEAKING THROUGH DRESSING. PATIENT WAS ADVISED BY HELPLINE NURSE TO ATTEND UNIT FOR ASSESSMENT. PICC LINE ASSESSED, LEAKAGE NOTICED ON DRESSING FLUSH/BLOOD STAINED, DRESSING REMOVED AND FRACTURE NOTICED JUST ABOVE SECUREACATH. ADVISED TO REMOVE PICC LINE BY PICC PLACER, PATIENT CONSENTED AND PROCEDURE EXPLAINED. PICC INSERTED IN THE BASILIC VEIN IN INTERVENTIONAL RADIOLOGY, USED FOR A CT SCAN, NO UNBLOCKING INTERVENTIONS CARRIED OUT, USED FOR SACT, CAUSED A DELAY IN TREATMENT BUT NO HARM. PICC REQUIRED TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1381599 POWERPICC SOLO2 PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LJS C.R. BARD, INC. (BASD) -3006260740 N/A REJU1543 00801741139079

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other