BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8723980 · Received June 21, 2019

    Report

    Report Number
    3006260740-2019-01734
    Event Type
    Malfunction
    Date Received
    June 21, 2019
    Date of Event
    May 28, 2019
    Report Date
    September 9, 2019
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    UDI-DI
    00801741138973
    PMA / PMN Number
    K091324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    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 KINKED CATHETER WAS CONFIRMED AND THE CAUSE APPEARED TO BE USE-RELATED. THE PRODUCT RETURNED FOR EVALUATION WAS ONE 4FR S/L POWERPICC SOLO CATHETER. USAGE RESIDUES WERE OBSERVED THROUGHOUT THE SAMPLE. A PERMANENT KINK IMPRESSION WAS OBSERVED NEAR THE 5CM DEPTH MARKING. CURVED SHAPE MEMORY WAS OBSERVED IN THE VICINITY OF THE KINK. MICROSCOPIC INSPECTION OF THE SAMPLE CONFIRMED A KINK IMPRESSION. MATERIAL BUCKLING AND SURFACE ABRASION WAS OBSERVED IN THE VICINITY OF THE KINK. THE MATERIAL BUCKLING AND SURFACE ABRASION SUGGESTED THAT THE CATHETER WAS KINKED REPEATEDLY. THE USAGE RESIDUES AND EVENT DESCRIPTION INDICATED THAT KINKING OCCURRED DURING DEVICE USE. THE LOCATION OF THE DAMAGE SUGGESTED THAT CATHETER INSERTION/SECUREMENT MAY HAVE CONTRIBUTED. THE PRODUCT IFU STATES ¿AVOID SHARP OR ACUTE ANGLES DURING IMPLANTATION WHICH COULD COMPROMISE THE PATENCY OF THE CATHETER LUMEN.¿ A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PICC WAS INSERTED IN THE RIGHT BRACHIAL VEIN. THE NEXT MORNING THE STAFF WERE NOT ABLE TO FLUSH THE LINE. ON ASSESSMENT THE LINE, IT WAS STATED IT WOULD NOT BUDGE UNLESS THE PATIENT TUCKED HER ARM IN TIGHT AT HER SIDE. PATIENT ALSO COMPLAINED OF PAIN AT ABOUT 3 INCHES UP FROM THE INSERTION SITE WITH A TENDER SPOT AND WAS HAVING TROUBLE USING THE ARM FROM THE PAIN.USER ELECTED TO REMOVE THE LINE AND A KINK WAS NOTED IN THE LINE AT THE 5CM MARK. IT WAS STATED THE DRESSING HAD NOT BEEN TOUCHED AS IT WAS NOT 24HOURS OLD.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PICC WAS INSERTED IN THE RIGHT BRACHIAL VEIN. THE NEXT MORNING THE STAFF WERE NOT ABLE TO FLUSH THE LINE. ON ASSESSMENT THE LINE, IT WAS STATED IT WOULD NOT BUDGE UNLESS THE PATIENT TUCKED HER ARM IN TIGHT AT HER SIDE. PATIENT ALSO COMPLAINED OF PAIN AT ABOUT 3 INCHES UP FROM THE INSERTION SITE WITH A TENDER SPOT AND WAS HAVING TROUBLE USING THE ARM FROM THE PAIN. USER ELECTED TO REMOVE THE LINE AND A KINK WAS NOTED IN THE LINE AT THE 5CM MARK. IT WAS STATED THE DRESSING HAD NOT BEEN TOUCHED AS IT WAS NOT 24HOURS OLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518796 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 RECZ2731 00801741138973

    Patients

    Seq Age Sex Outcome Treatment
    1