BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICC SOLO CATHETER WITH SHERLOCK 3CG (TPS) STYLET 4F FULL TRAY

    MDR report key: 19220371 · Received May 1, 2024

    Report

    Report Number
    3006260740-2024-01971
    Event Type
    Malfunction
    Date Received
    May 1, 2024
    Date of Event
    April 8, 2024
    Report Date
    September 4, 2024
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    PMA / PMN Number
    K091324
    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. THE COMPLAINT OF A LEAK WAS CONFIRMED AND DETERMINED TO BE USE RELATED. THE PRODUCT RETURNED FOR EVALUATION WAS ONE 4 FR SL POWERPICC SOLO 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 IN THE CATHETER TUBING BETWEEN THE 6 CM AND 7 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) 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED, "PRESENTED WITH A LEAKING LINE . SMALL LEAK ABOUT 2 CMS UNDER THE SKIN PAST INSERTION SITE''. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED FOR THIS EVENT AS PART OF A FOCUS SURVEY. THE FOLLOWING ADDITIONAL DETAIL WAS PROVIDED: PICC INSERTED INTO BASILIC VEIN. EXIT SITE MARKING OF THE PICC AFTER PLACEMENT 12CM. THIS AMOUNT OF CATHETER LENGTH LEFT EXTERNAL TO THE INSERTION SITE BECAUSE OVER GENEROUS WHEN PLACING, TARGET IS 8CM SO THEY CAN DO J-LOOP, EASIER TO KINK SOLO THAN GROSHAN. FRENCH SIZE OF THE SECURACATH DEVICE 4FR. TYPES OF INFUSATES INFUSED THROUGH THE DEVICE ARE GLUCOSE FLUSH, OXALIPALTIN, FOLINETE, BREAK WAS OUTSIDE THE PATIENT AT THE 3CM MARK, 48 DAYS AFTER INSERTION. PATIENT IN THE HOSPITAL WHEN THE PICC LEAKAGE WAS IDENTIFIED. SIZE AND ACTIVE INGREDIENTS OF THE STERILE SUPPLIES USED TO CLEAN THE CATHETER SITE DURING A DRESSING CHANGE: CHLORAPREP SPONGE> PATIENT WAS RECOMMENDED LIGHT EXERCISE.

    Description of Event or Problem · 0

    IT WAS REPORTED, "PRESENTED WITH A LEAKING LINE . SMALL LEAK ABOUT 2 CMS UNDER THE SKIN PAST INSERTION SITE''. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2138288 POWERPICC SOLO CATHETER WITH SHERLOCK 3CG (TPS) STYLET 4F FULL TRAY CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS C.R. BARD, INC. (BASD) -3006260740 N/A REHS1889

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Other