BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER PICC HF CATHETER WITH SHERLOCK

    MDR report key: 4894286 · Received July 2, 2015

    Report

    Report Number
    3006260740-2015-00304
    Event Type
    Malfunction
    Date Received
    July 2, 2015
    Date of Event
    April 15, 2015
    Report Date
    June 11, 2015
    Manufacturer
    BARD ACCESS SYSTEMS INC.
    Product Code
    LJS
    PMA / PMN Number
    K091324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY BARD 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 BARD. THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, TREND ANALYSIS, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE (IF AVAILABLE), APPLICABLE FMEA DOCUMENTS, LABELING, AND APPLICABLE MANUFACTURE RECORDS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A LEAKING CATHETER WAS CONFIRMED; HOWEVER, THE PRECISE CAUSE WAS UNDETERMINED. THE PRODUCT RETURNED FOR EVALUATION WAS ONE 5FR T/L POWERPICC CATHETER. THE SAMPLE TERMINATED AT THE 41CM DEPTH MARKING. MICROSCOPIC INSPECTION OF THE DISTAL TIP OF THE SAMPLE REVEALED STRIATIONS TYPICAL OF A SHARP INSTRUMENT CUT. A LONGITUDINALLY ALIGNED SPLIT WAS OBSERVED BETWEEN THE 2CM AND 3CM DEPTH MARKINGS, WITHIN THE REGION OF THE REVERSE TAPER. AN ATTEMPT TO INFUSE WATER THROUGH THE SAMPLE USING A 12ML SYRINGE REVEALED THE GREY LUMEN TO BE PATENT TO INFUSION; HOWEVER, A SPRAYING LEAK WAS OBSERVED EMANATING FROM THE SITE OF THE AFOREMENTIONED SPLIT. THE RED AND WHITE LUMENS WERE EACH PATENT TO INFUSION AND ASPIRATION WITH NO OBSERVED LEAKS. THE CATHETER KINKED PREFERENTIALLY IN THE VICINITY OF THE SPLIT DURING MANUAL MANIPULATION. MATERIAL DISCOLORATION WAS OBSERVED AT THE SITES OF PREFERENTIAL KINKING. MICROSCOPIC INSPECTION OF THE SPLIT REVEALED SHARPLY DEFINED EDGES. THE SPLIT EDGES EXHIBITED A FINELY GRANULAR TEXTURE. THE MATERIAL DISCOLORATION AND PREFERENTIAL KINKING SUGGESTED THAT THE METHOD USED TO SECURE THE CATHETER MAY HAVE CAUSED OR CONTRIBUTED TO THE OBSERVED LEAK; HOWEVER, INSUFFICIENT INFORMATION WAS PROVIDED TO CONCLUSIVELY IDENTIFY THIS AS THE ROOT CAUSE. CONSEQUENTLY, THIS COMPLAINT IS CONFIRMED AS ¿CAUSE UNKNOWN¿ AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A LOT HISTORY REVIEW (LHR) OF REZB1059 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THESE LOT NUMBERS. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER, AT THIS TIME, FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2015, IT WAS REPORTED THAT THE NURSE INVESTIGATED PROBLEMS WITH PICC AND POSSIBLE INFILTRATION. LINE APPEARED TO BE INTACT WITH TRIPLE LUMEN. THE GREY PORT HAD REPORTEDLY BEEN DOCUMENTED AS BEING DIFFICULT TO FLUSH FOR THREE DAYS. SWELLING WAS NOTED DISTAL TO THE PICC. NURSE TRIED TO FLUSH THE GREY PORT; THE FLUSHING COULD BE FELT BY PALPATION 3-4 CM ABOVE THE INSERTION SITE, AND ALLEGEDLY CAUSED PAIN TO THE PATIENT. THE LINE WAS REMOVED AND REPLACED BY PERIPHERAL LINE. THE PICC WAS ASSESSED AND WAS REPORTEDLY NOTED TO HAVE A RUPTURE AT THE 3-4 CM MARK. THE PATIENT DID NOT SUSTAIN HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431431 POWER PICC HF CATHETER WITH SHERLOCK LJS BARD ACCESS SYSTEMS INC. REZB1059

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR