BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 4F

    MDR report key: 9728903 · Received February 19, 2020

    Report

    Report Number
    3006260740-2020-00561
    Event Type
    Malfunction
    Date Received
    February 19, 2020
    Date of Event
    January 27, 2020
    Report Date
    March 20, 2020
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    UDI-DI
    00801741138973
    PMA / PMN Number
    K091324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    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, COMPLAINT AND LOT HISTORY, APPLICABLE PREVIOUS INVESTIGATION(S), LABELING, APPLICABLE MANUFACTURING RECORDS, AND APPLICABLE FMEA DOCUMENTS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A LEAK WAS CONFIRMED AND APPEARS TO BE RELATED TO THE USE OF THE DEVICE. ONE 4 FR POWERPICC SOLO CATHETER WAS PROVIDED FOR INVESTIGATION. THE CATHETER EXTENDED UP TO THE 49 CM DEPTH MARKER. THE SAMPLE WAS FLUSHED WITH WATER USING A 12 ML SYRINGE AND A LEAK WAS OBSERVED NEAR THE 20 CM DEPTH MARKER. MICROSCOPIC OBSERVATION OF THE LEAK LOCATION REVEALED A CIRCUMFERENTIAL SPLIT. A LONGITUDINAL SPLIT WAS PRESENT AT THE EDGE LOCATION OF THE SPLIT. MATERIAL WRINKLING WAS PRESENT ALONG THE BREAK EDGES. THE BREAK SURFACE CHARACTERISTICS ARE CONSISTENT WITH DAMAGE CAUSED BY REPEATED KINKING OF THE CATHETER LEADING TO MATERIAL FATIGUE. THE PRODUCT INSTRUCTIONS FOR USE (IFU) STATES, "AVOID PLACEMENT OR SECUREMENT OF THE CATHETER WHERE KINKING MAY OCCUR, TO MINIMIZE STRESS ON THE CATHETER, PATENCY PROBLEMS OR PATIENT DISCOMFORT." THE CATHETER WAS CUT NEAR THE SPLIT LOCATION IN ORDER TO MEASURE THE WALL THICKNESS. THE CATHETER WALL THICKNESS WAS FOUND TO BE WITHIN MANUFACTURING SPECIFICATION. SINCE A SPLIT WAS OBSERVED TO BE THE CAUSE OF THE LEAK, THE COMPLAINT IS CONFIRMED. A LOT HISTORY REVIEW (LHR) OF REDR3332 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT HAD HER PICC-LINE 251019. WHEN THEY FLUSHED THE CATHETER TODAY THEY DISCOVERED SALINE COMING FROM INSERTPLACE. THEY PULLED OUT THE CATHETER AND THERE WAS A HOLE 20CM FROM THE BULB ON THE CATHETER. THE PATIENT HAD CYTOSTATIC DRUGS EPIRUBICIN AND CYKLOFOSFAMID FROM THE START. THE PATIENT HAD FIXED THE PICC WITH SECURE A CATH. (B)(6)2020 -EXTERNAL CATHETER LENGTH WAS 3.2 CM FROM INSERTION SITE.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF REDR3332 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD HER PICC-LINE 251019. WHEN THEY FLUSHED THE CATHETER TODAY THEY DISCOVERED SALINE COMING FROM INSERT PLACE. THEY PULLED OUT THE CATHETER AND THERE WAS A HOLE 20CM FROM THE BULB ON THE CATHETER. THE PATIENT HAD CYTOSTATIC DRUGS EPIRUBICIN AND CYCLOPHOSPHAMID FROM THE START. THE PATIENT HAD FIXED THE PICC WITH SECURE A CATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193217 POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 4F CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS BARD ACCESS SYSTEMS N/A REDR3332 00801741138973

    Patients

    Seq Age Sex Outcome Treatment
    1