BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM

    MDR report key: 11473814 · Received March 12, 2021

    Report

    Report Number
    3006260740-2021-00791
    Event Type
    Malfunction
    Date Received
    March 12, 2021
    Date of Event
    February 18, 2021
    Report Date
    September 22, 2021
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    PMA / PMN Number
    K091324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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, TREND ANALYSIS, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE (IF AVAILABLE), AND APPLICABLE FMEA DOCUMENTS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A LEAKING CATHETER WAS CONFIRMED. THE PRODUCT RETURNED FOR EVALUATION WAS ONE 4FR S/L POWERPICC SOLO CATHETER. USAGE RESIDUES WERE OBSERVED THROUGHOUT THE SAMPLE. A PARTIALLY CIRCUMFERENTIAL SPLIT WAS OBSERVED NEAR THE 12CM DEPTH MARKING. THE SPLIT OCCURRED WITHIN A PERMANENT KINK IMPRESSION. THE CATHETER KINKED PREFERENTIALLY AT THE SPLIT SITE DURING MANUAL MANIPULATION. MICROSCOPIC INSPECTION OF THE SPLIT REVEALED DULLY GRANULAR, INWARD CURVING EDGES. MATERIAL WEAR, BUCKLING AND DISCOLORATION WERE OBSERVED IN THE VICINITY OF THE SPLIT. THE SPLIT WAS CONSISTENT WITH DAMAGE ACCUMULATED THROUGH FLEXURAL FATIGUE. FLEXURAL FATIGUE OCCURS WHEN REPETITIVE MECHANICAL STRESSES SUCH AS KINKING GRADUALLY CAUSE A FRACTURE TO FORM AND PROPAGATE IN THE CATHETER MATERIAL. THE LOCATION OF THE DAMAGE SUGGESTED THAT CATHETER SECUREMENT, ACCESS AND MAINTENANCE TECHNIQUES MAY HAVE CONTRIBUTED.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE PATIENT HAS HAD THE PICC SINCE (B)(6) 2020, WHEN THE CATHETER WAS REMOVED A HOLE WAS NOTED 12 CM FROM THE HUB. NO OTHER INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF REER0493 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT HAS HAD THE PICC SINCE 10/05/2020, WHEN THE CATHETER WAS REMOVED A HOLE WAS NOTED 12 CM FROM THE HUB. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367173 POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS C.R. BARD, INC. (BASD) -3006260740 N/A REER0493

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other