BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM

    MDR report key: 14719001 · Received June 16, 2022

    Report

    Report Number
    3006260740-2022-02302
    Event Type
    Malfunction
    Date Received
    June 16, 2022
    Date of Event
    May 23, 2022
    Report Date
    July 28, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF REFV2245 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    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 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 JUST PROXIMAL OF THE 11CM 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 ¿ 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) AN EXAMINATION OF THE CATHETER STRUCTURE REVEALED NO POTENTIAL DAMAGE/DEFECT RELATED TO MANUFACTURE OF THE PRODUCT. THE DAMAGE LOCATION SUGGESTED THAT CATHETER SECUREMENT, ACCESS AND MAINTENANCE TECHNIQUES MAY HAVE CONTRIBUTED. H3 OTHER TEXT : EVALUATION FINDINGS ARE IN SECTION H.11.

    Description of Event or Problem · 0

    IT WAS REPORTED, "PATIENT GOT A PICC 220209. NOW THEY SAW A HOLE IN IT WHEN THEY PULLED IT OUT. THEY HAVE HAD PROBLEMS WITH THE FLOW BUT IT WORKED. NOW IT WAS STOP IN IT AND WHEN THEY PULLED IT OUT THEY SAW A HOLE IN THE CATHETER 15 CM FROM THE HUB. THE PATIENT WAS NOT HARMED BUT SHE NEEDED A NEW PICC."

    Description of Event or Problem · 0

    IT WAS REPORTED, "PATIENT GOT A PICC 220209. NOW THEY SAW A HOLE IN IT WHEN THEY PULLED IT OUT. THEY HAVE HAD PROBLEMS WITH THE FLOW BUT IT WORKED. NOW IT WAS STOP IN IT AND WHEN THEY PULLED IT OUT THEY SAW A HOLE IN THE CATHETER 15 CM FROM THE HUB. THE PATIENT WAS NOT HARMED BUT SHE NEEDED A NEW PICC."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2208026 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 REFV2245

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other