BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICC SOLO2 CATHETER BASIC TRAY (4F) (SINGLE-LUMEN)

    MDR report key: 11933863 · Received June 3, 2021

    Report

    Report Number
    3006260740-2021-02152
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Date of Event
    May 13, 2021
    Report Date
    June 24, 2021
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    PMA / PMN Number
    K072230
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, COMPLAINT AND LOT HISTORY, APPLICABLE PREVIOUS INVESTIGATION(S), LABELING, APPLICABLE MANUFACTURING RECORDS, RETURNED SAMPLE EVALUATION, AND APPLICABLE FMEA DOCUMENTS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF CATHETER LEAK WAS CONFIRMED. THE PRODUCT RETURNED FOR EVALUATION WAS 4FR S/L POWERPICC CATHETER. THE INVESTIGATION FINDINGS ARE CONSISTENT WITH DAMAGE ACCUMULATED THROUGH FLEXURAL FATIGUE. FLEXURAL FATIGUE OCCURS 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 20CM AND 21CM DEPTH MARKING. 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 OVERALL ELLIPTICAL SHAPE TO THE FRACTURE CROSS-SECTION (A RESULT OF REPEATED KINKING OF THE TUBING) AN EXAMINATION OF THE CATHETER STRUCTURE REVEALED NO POTENTIAL DAMAGE/DEFECT RELATED TO MANUFACTURE OF THE PRODUCT. H3 OTHER TEXT : EVALUATION FINDINGS ARE IN SECTION H.11

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD THE POWERPICC SOLO CATHETER PLACED FROM THE RIGHT ARM UNDER ULTRASOUND ON (B)(6), 2021. 39 CM OF THE CATHETER WAS INSERTED INTERNALLY. ON (B)(6), 2021, FLUIDS LEAKED FROM THE INSERTION SITE. THE CATHETER WAS PULLED OUT AND FOUND IT RUPTURED NEAR THE 20 CM SCALE.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL EVALUATE. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) OF REES1463 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THE POWERPICC SOLO CATHETER PLACED FROM THE RIGHT ARM UNDER ULTRASOUND ON (B)(6) 2021. 39 CM OF THE CATHETER WAS INSERTED INTERNALLY. ON (B)(6) 2021, FLUIDS LEAKED FROM THE INSERTION SITE. THE CATHETER WAS PULLED OUT AND FOUND IT RUPTURED NEAR THE 20 CM SCALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823897 POWERPICC SOLO2 CATHETER BASIC TRAY (4F) (SINGLE-LUMEN) CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS C.R. BARD, INC. (BASD) -3006260740 N/A REES1463

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other