BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERPICC SOLO2, 3CG

    MDR report key: 22799210 · Received August 13, 2025

    Report

    Report Number
    3006260740-2025-05872
    Event Type
    Injury
    Date Received
    August 13, 2025
    Date of Event
    July 29, 2025
    Report Date
    September 23, 2025
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    UDI-DI
    00801741102660
    PMA / PMN Number
    UNK
    Removal / Correction Number
    MDS-24-5154-C
    Adverse Event
    Yes
    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 BETWEEN THE 10 CM AND 11 CM DEPTH MARKERS. 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). THE CATHETER TUBING WAS ALSO OBSERVED TO BE COMPRESSED AT THE SPLIT SITE. 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 THAT WHILE PLACING TUBIFAST DRESSING OVER PICC POST ADMINISTRATION OF CHEMOTHERAPY, SN NOTICED POCKET OF ORANGE/RED FLUID INSIDE DRESSING. PICC LEAKING SERIOUS FLUID. PICC PLACER INFORMED OF SUSPECTED FRACTURE WITH EXTRAVASATION OF VESICANT CHEMOTHERAPY. EXTRAVASATION PATHWAY COMMENCED. PICC REMOVED AND FRACTURE NOTED AT THE 10CM MARK. CATHETER WAS INSERTED IN CATH LAB WITH 6CM EXIT SITE MARKINGS. ADDITIONAL INFORMATION PROVIDED: THE PATIENT HAD TO BE TREATED FOR POSSIBLE EXTRAVASATION OF A VESICANT SACT. THIS REQUIRED FURTHER ATTENDANCES TO UNIT FOR FACE TO FACE ASSESSMENTS. ALSO REQUIRES ANOTHER PICC INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88162 POWERPICC SOLO2, 3CG PERIPHERALLY INSERTED CENTRAL CATHETER LJS C.R. BARD, INC. (BASD) -3006260740 N/A REJS0058 00801741102660

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention