BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICC

    MDR report key: 23074968 · Received September 17, 2025

    Report

    Report Number
    3006260740-2025-07018
    Event Type
    Malfunction
    Date Received
    September 17, 2025
    Date of Event
    September 3, 2025
    Report Date
    November 7, 2025
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    UDI-DI
    00801741138966
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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. THE COMPLAINT OF A DAMAGED CATHETER WAS CONFIRMED. THE PRODUCT RETURNED FOR EVALUATION WAS ONE 4 FR SINGLE LUMEN POWERPICC 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 SMALL SPLIT WAS OBSERVED BETWEEN THE 5 CM AND 6 CM DEPTH MARKERS AND ALSO A SECOND SPLIT WAS OBSERVED BETWEEN THE 8 CM AND 9 CM DEPTH MARKERS. THE CATHETER SPLITS 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.

    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 DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PICC WAS REMOVED WITH A PORE AT 8 CM. PATIENT HAS UNDERGONE 4 CYCLES OF QMT TREATMENT (WEEKLY CISPLATIN). ARM CIRCUMFERENCE: 38 CM VEIN CALIBER: 4.1 MM DEPTH: 2 CM BASILICA VEIN CANNULATED. 38 CM OF CATHETER INSERTED. SECURACATH USED FOR FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2668314 POWERPICC PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LJS C.R. BARD, INC. (BASD) -3006260740 N/A REJX1835 00801741138966

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other