BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICC SV CATHETER 4F BASIC TRAY

    MDR report key: 11532447 · Received March 19, 2021

    Report

    Report Number
    3006260740-2021-00920
    Event Type
    Malfunction
    Date Received
    March 19, 2021
    Date of Event
    January 9, 2021
    Report Date
    May 17, 2021
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    PMA / PMN Number
    K102159
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 REVIEW, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE (IF AVAILABLE), LABELING, APPLICABLE MANUFACTURE RECORDS, AND APPLICABLE FMEA DOCUMENTS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A LEAKS IS CONFIRMED; HOWEVER, THE EXACT CAUSE IS UNKNOWN. ONE 4 FR DUAL LUMEN POWERPICC SV CATHETER WAS RETURNED FOR EVALUATION. AN INITIAL VISUAL OBSERVATION SHOWED USE RESIDUE ON THE RETURNED SAMPLE. AN APPROXIMATELY 0.8 CM LONG LONGITUDINAL SPLIT WAS OBSERVED IN THE RED LUMEN OF THE CATHETER AROUND THE 4 CM DEPTH MARKER. A MICROSCOPIC OBSERVATION REVEALED THE LARGE SPLIT WAS MADE UP OF AT LEAST TWO INDIVIDUAL SPLITS WHICH WERE SEPARATED BY A THIN STRIP OF MATERIAL. THE SPLITS WERE OBSERVED TO BE STRAIGHT WITH CLEAN EDGES AND FLAT AND GRANULAR FRACTURE SURFACES. IT COULD BE SEEN IN ONE CORNER OF THE SPLIT THAT THE DAMAGE LIKELY ORIGINATED FROM THE EXTERNAL SIDE OF THE CATHETER WALL. THE CATHETER AROUND THE AREA OF THE SPLIT WAS OBSERVED TO BE SOMEWHAT FLATTENED. THE FEATURES OF THE OBSERVED SPLITS SUGGEST THE CATHETER WAS POSSIBLY DAMAGED DUE TO PROLONGED CIRCUMFERENTIAL COMPRESSION, WHICH COULD BE CAUSED BY SOME DRESSING DEVICES AND/OR DRESSING TECHNIQUES. HOWEVER, THE EXACT CAUSE OF THE DAMAGE OBSERVED IN THE RETURNED CATHETER COULD NOT BE DETERMINED. A LOT HISTORY REVIEW (LHR) OF REEW1812 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER (REEW1812) HAVE BEEN REPORTED FROM THE SAME FACILITY. H3 OTHER TEXT : EVALUATION FINDINGS ARE IN SECTION H.11.

    Description of Event or Problem · 0

    IT WAS REPORTED 4FR DUAL LUMEN POWERPICC WAS REMOVED DUE TO FRACTURED/LEAKING. ADDITIONAL INFO. RECEIVED: "BOTH LUMENS WITH CONTINUOUS INFUSIONS UNTIL 1/9/21 @ 0510, BOTH LUMENS HEPARIN LOCKED, FLUSHED EASILY. 01/9/21 @ 0930 SANGUINEOUS DRAINAGE NOTED ON DRESSING; VASCULAR ACCESS TEAM NOTIFIED WITH REPORT THAT THE CATHETER WAS LEAKING FROM THE SECURACATH SITE. DRESSING WAS TAKEN DOWN AND COVER WAS REMOVED FROM THE SECURACATH. THE CATHETER WAS FLUSHED AND LEAKING WAS NOTED FROM THE CATHETER THAT WAS POSITIONED ABOUT MIDWAY ALONG THE BASE OF THE SECURACATH. THE CATHETER WAS POSITIONED IN PROPER ALIGNMENT WITHIN CHANNEL OF SECURACATH. PICC WAS REMOVED. NO PT. HARM REPORTED." "PICC PLACED IN THE LEFT UPPER ARM, BASILIC VEIN, WITH 7 CM EXTERNAL CATHETER LENGTH, CATHETER TIP AT THE CAVOATRIAL JUNCTION."

    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 4FR DUAL LUMEN POWERPICC WAS REMOVED DUE TO FRACTURED/LEAKING. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419452 POWERPICC SV CATHETER 4F BASIC TRAY CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS C.R. BARD, INC. (BASD) -3006260740 N/A REEW1812

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other