BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFM PICC II

    MDR report key: 2854739 · Received November 29, 2012

    Report

    Report Number
    2032582-2012-00013
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    March 11, 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 COMPLAINT. A REVIEW OF SIMILAR COMPLAINTS WAS CONDUCTED AS FAR BACK AS 2008 REVEALED THAT ONE (1) SIMILAR COMPLAINT WAS REPORTED TO PFM IN (B)(4) OF 2012 ((B)(4) / FDA MDR# 2032582-2012-00007). SINCE 2011, PFM MANUFACTURED/SOLID 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 #1108-012 ARE COMPLETE AND IN ORDER. NO NONCONFORMITIES 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 FROM THE SIMILAR LOT TESTED ON ALL PASSED; NONE OF THE SAMPLES LEAKED WHEN FLUIDS WERE INFUSED THROUGH THE INFECTION 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 DEVICE. PFM WILL CONTINUE TO MONITOR FUTURE INCIDENTS OF THIS KIND.

    Description of Event or Problem · 1

    ON (B)(6) 2012, FOUR (4) REPORTS WERE PROVIDED TO PFM WITH SIMILAR PROBLEMS AND THEY WERE SPLIT INTO FOUR SEPARATE CASES (REF MDR#203582-2012-00010 THROUGH 203582-2012-00013). THE DISTRIBUTOR HAD PROVIDED INFO ON THESE 4 REPORTS ALL ON THE SAME DAY INSTEAD OF SUBMITTING THEM AS INFO BECAME AVAILABLE. THE FOURTH (4TH) CASE STATED THE FOLLOWING COMPLAINT: "CRACKED RED PORT 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