BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICC HF CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 5F M

    MDR report key: 9142531 · Received October 1, 2019

    Report

    Report Number
    3006260740-2019-02900
    Event Type
    Malfunction
    Date Received
    October 1, 2019
    Report Date
    October 18, 2019
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    UDI-DI
    00801741034657
    PMA / PMN Number
    K091324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, COMPLAINT AND LOT HISTORY REVIEW, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE (IF AVAILABLE), LABELING, AND APPLICABLE FMEA DOCUMENTS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A LEAK IS CONFIRMED AND WAS DETERMINED TO BE USE RELATED. ONE 5 FR TRIPLE LUMEN POWER PICC PROVENA CATHETER WAS RETURNED FOR EVALUATION. AN INITIAL VISUAL OBSERVATION SHOWED USE RESIDUE ON THE RETURNED SAMPLE. A LONGITUDINAL SPLIT WAS OBSERVED IN THE CATHETER NEAR THE 3 CM DEPTH MARKER, APPROXIMATELY 4.1 CM DISTAL TO THE MOLDED JOINT AND WAS MEASURED TO BE ABOUT 1 MM LONG. SOME SLIGHT TENSILE WEAKNESS WAS OBSERVED IN THE CATHETER NEAR THE LOCATION OF THE SPLIT. A MICROSCOPIC OBSERVATION REVEALED THE SPLIT WAS MOSTLY STRAIGHT WITH SLIGHTLY RIPPLED EDGES, AND THE FRACTURE SURFACES WERE OBSERVED TO BE FLAT AND GRANULAR IN TEXTURE. THE DAMAGE OBSERVED IN THE RETURNED SAMPLE WAS CHARACTERISTIC OF OVER-PRESSURIZATION (BURST) DAMAGE. THIS CAN OCCUR THROUGH THE USE OF SYRINGES SMALLER THAN 10ML, BY FLUSHING AGAINST AN OCCLUSION, OR DUE TO EXCESSIVE FORCE APPLIED DURING INFUSION PROCEDURES. A LOT HISTORY REVIEW (LHR) OF REDN3903 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TEAM COMPLAINED OF LEAKING PICC. UPON FLUSHING, NOTICED A PIN HOLE SPRAY APPROX. 4 CM FROM THE HUB. PICC HAD TO BE DC'D BASED ON LEAK ON GREY PORT. NO PATIENT HARM REPORTED. PATIENT WAS JUST FINISHING UP ANTIBIOTICS SO DC'D AND REPLACED WITH NEW PICC. (B)(6) 2019- UPDATED INFO FROM TM STATED, "THE LINE WAS PLACED ON 3/27 AND WAS DC¿D ON 4/5 DUE TO LEAKING ON THE GRAY PORT. THE PATIENT DID EXPERIENCE AN INFILTRATION DUE TO THE LEAK AND PICC WAS DC¿D BECAUSE OF IT."

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL EVALUATE. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) OF REDN3903 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TEAM COMPLAINED OF LEAKING PICC. UPON FLUSHING, NOTICED A PIN HOLE SPRAY APPROX. 4 CM FROM THE HUB. PICC HAD TO BE DC'D BASED ON LEAK ON GREY PORT. NO PATIENT HARM REPORTED. PATIENT WAS JUST FINISHING UP ANTIBIOTICS SO DC'D AND REPLACED WITH NEW PICC. 9/11/20169- UPDATED INFO FROM TM STATED, "THE LINE WAS PLACED ON 3/27 AND WAS DC¿D ON 4/5 DUE TO LEAKING ON THE GRAY PORT. THE PATIENT DID EXPERIENCE AN INFILTRATION DUE TO THE LEAK AND PICC WAS DC¿D BECAUSE OF IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937021 POWERPICC HF CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 5F M CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS BARD ACCESS SYSTEMS N/A REDN3903 00801741034657

    Patients

    Seq Age Sex Outcome Treatment
    1