BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFM PICC II

    MDR report key: 2854728 · Received November 29, 2012

    Report

    Report Number
    2032582-2012-00012
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    June 14, 2012
    Report Date
    November 27, 2012
    Manufacturer
    PFM MEDICAL, INC.
    Product Code
    LJS
    PMA / PMN Number
    K083873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING REVIEWS WERE CONDUCTED AND THEIR RESPECTIVE RESULTS WERE FOUND: THERE IS NO IMPACT TO CURRENT INVENTORY AS NO FURTHER SHIPMENTS ARE PLANNED TO BE SENT TO THE COMPLAINANT. A REVIEW OF SIMILAR COMPLAINTS WAS CONDUCTED AS FAR BACK AS 2008 REVEALED THAT NO SIMILAR INCIDENTS OF THIS NATURE HAD BEEN REPORTED TO PFM. SINCE 2011, PFM MANUFACTURED / SOLD 8,164 5F DUAL LUMEN PICC'S. THE RISK OF "CRACKED VALVE" AND "CATHETER LEAK" WAS IDENTIFIED IN THE RISK ANALYSIS. A DHR REVIEW REVEALED THAT THE QUALITY RECORDS FOR LOT# 1111-012 ARE COMPLETE AND IN ORDER. NO NON-CONFORMITIES ARE ASSOCIATED WITH THIS LOT. THE SUSPECTED/FAILED DEVICE WAS NOT RETURNED TO PFM. THEREFORE, WE WERE UNABLE TO TEST THE ACTUAL FAILED DEVICE. INSTEAD, PICCS FROM A SIMILAR LOT WERE TESTED. FOLLOWING 3 DAYS OF SIMULATED USE, NO CRACKING, CRAZING OR LEAKAGE OF FLUIDS WAS OBSERVED. EACH SAMPLE TESTED ALL PASSED; NONE OF THE SAMPLES LEAKED WHEN FLUIDS WERE INFUSED THROUGH THE INJECTION PORT. DUE TO NOT HAVING THE ACTUAL FAILED DEVICE FOR TESTING, AND TESTING ON INVENTORY SAMPLES ALL PASSED, PFM IS UNABLE TO DETERMINE THE ROOT CAUSE OF THE FAILED DEVICES. PFM WILL CONTINUE TO MONITOR FUTURE INCIDENTS OF THIS KIND.

    Description of Event or Problem · 1

    AT AN UNSPECIFIED DATE/TIME, "THE PROBLEM WAS INITIALLY BROUGHT TO THEIR ATTENTION WHEN THEY WERE TOLD THAT SEVERAL PORTS HAD CRACKED BUT THE INFO WAS NOT MADE AVAILABLE, SO THEY DID NOT FILE A REPORT TO PFM. AS THE PROBLEMS PROGRESSED THEY BEGAN TO PROVIDE NAMES TO IT WAS FINALLY REPORTED TO PFM." ON (B)(4) 2012, FOUR (4) REPORTS WERE PROVIDED TO PFM WITH SIMILAR PROBLEMS AND WE SPLIT THEM INTO FOUR SEPARATE CASES (REF MDR# 203582-2012-00010-13/ PSR00379-382) BECAUSE THE DISTRIBUTOR HAD PROVIDED INFO ON THESE 4 REPORTS ALL ON THE SAME DAY INSTEAD OF SUBMITTING THEM AS INFO BECAME AVAILABLE. THE THIRD CASE INCLUDING THE FOLLOWING COMPLAINT: "PICC PORT LEAKING REQUIRING REPLACEMENT ON (B)(6) 2012."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFM PICC II PICC LJS PFM MEDICAL, INC. 1111-012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention