BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16500572 · Received March 8, 2023

    Report

    Report Number
    3006260740-2023-00704
    Event Type
    Malfunction
    Date Received
    March 8, 2023
    Date of Event
    February 9, 2023
    Report Date
    April 12, 2023
    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

    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. BASED ON A REVIEW OF AVAILABLE COMPLAINT INFORMATION AND AN EVALUATION OF THE AVAILABLE SAMPLE EVIDENCE, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF WATER EXITING THE HOSE IS CONFIRMED. ONE 4 FR S/L POWERPICC SOLO WAS RETURNED FOR EVALUATION. AN INITIAL VISUAL OBSERVATION SHOWED ABUNDANT USE RESIDUES THROUGHOUT THE DEVICE. A FUNCTIONAL TEST OF PRESSURIZING THE RETURNED POWERPICC USING WATER AND A 12 ML SYRINGE REVEALED A HOLE IN THE TUBING PROXIMAL OF THE MOLDED JOINT. A MICROSCOPIC OBSERVATION REVEALED THE HOLE IN THE TUBING PROXIMAL TO THE MOLDED JOINT APPEARED TO BE IN A CHEVRON SHAPE JUST DISTAL OF THE PRINTED ¿POWER INJECTABLE¿ LETTERING. AN OBSERVATION OF THE SPLIT REVEALED THE FRACTURE SURFACE TO HAVE PROMINENT STRIATIONS LIKE THAT OF A SHARP, BLADED INSTRUMENT. THE FRACTURE EDGES APPEARED TO BE SHARPLY FORMED. AN EXAMINATION OF THE CATHETER STRUCTURE REVEALED NO POTENTIAL DAMAGE/DEFECT RELATED TO MANUFACTURE OF THE PRODUCT. THE COMPLAINT OF DROPS VISIBLE FROM THE HOSE OF THE CATHETER IS CONFIRMED AND IS LIKELY DUE TO SHARP INSTRUMENT DAMAGE. THE STRIATIONS FOUND ON THE FRACTURE SURFACE, THE SHARP FRACTURE EDGES, AND THE CHEVRON SHAPE OF THE SPLIT ARE LIKELY DUE TO CONTACT WITH A GRIND-SHARPENED, PLANAR BLADE SUCH AS A SCALPEL. THE LOCATION OF THE DAMAGE SUGGESTED THAT CATHETER MAINTENANCE TECHNIQUES MAY HAVE CONTRIBUTED.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL EVALUATE. RESULTS ARE EXPECTED SOON. A BATCH HISTORY REVIEW (BHR) OF REGU1734 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED BY HEALTHCARE PROFESSIONAL, "PICC LINE INSERTED 230119. DURING TREATMENT 230209, HOLE IS DISCOVERED ON THE TUBE 28 MM PROXIMAL TO THE WINGS AFTER GIVEN TREATMENT. DISCOVERED THAT IT WAS WET IN THE BED AND UNDER THE TEGADERM. WHEN FLUSHING, DROPS ARE VISIBLE FROM THE HOSE. PREPARATIONS GIVEN WERE CYCLOPHOSPHAMIDE, DOXORUBICIN, VINCRISTINE AND RITUXIMAB. THERE WAS NO IMPACT ON THE PATIENT OTHER THAN DELAYED TREATMENT AND SPILLAGE OF CYTOSTATICS."

    Description of Event or Problem · 0

    IT WAS REPORTED BY HEALTHCARE PROFESSIONAL, "PICC LINE INSERTED 230119. DURING TREATMENT 230209, HOLE IS DISCOVERED ON THE TUBE 28 MM PROXIMAL TO THE WINGS AFTER GIVEN TREATMENT. DISCOVERED THAT IT WAS WET IN THE BED AND UNDER THE TEGADERM. WHEN FLUSHING, DROPS ARE VISIBLE FROM THE HOSE. PREPARATIONS GIVEN WERE CYCLOPHOSPHAMIDE, DOXORUBICIN, VINCRISTINE AND RITUXIMAB. THERE WAS NO IMPACT ON THE PATIENT OTHER THAN DELAYED TREATMENT AND SPILLAGE OF CYTOSTATICS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164830 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 REGU1734

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other