BEUDAMED
    FDA Adverse Event Other Summary report: N

    NAC-1820MLL

    MDR report key: 1898962 · Received November 12, 2010

    Report

    Report Number
    1056553-2010-00002
    Event Type
    Other
    Date Received
    November 12, 2010
    Date of Event
    September 9, 2010
    Report Date
    November 3, 2010
    Manufacturer
    REMINGTON MEDICAL, INC.
    Product Code
    KNW
    PMA / PMN Number
    K982401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SEVEN (7) (B)(4) SAMPLES FROM THE LOT IN QUESTION WERE RECEIVED FROM THE FACILITY REPORTING THE PATIENT INFECTIONS, AND ALL 7 WERE SENT OUT FOR STERILITY TESTING: A TOTAL OF 4 SAMPLES WERE TESTED IN FTM (FLUID THYOGLOCOLATE MEDIA) AND 3 SAMPLES WERE TESTED IN SCD (SOY CASEIN DIGEST MEDIA). THE PRODUCT WAS REPORTED AS NEGATIVE FOR GROWTH (ALL SAMPLES) PER LAB REPORT #(B)(4), DATED (B)(6) 2010. A REVIEW OF THE DHR FOR (B)(4), LOT #101824 SHOWS THAT ONE NCR WAS ISSUED TO THE WORK ORDER FOR A LABELING ISSUE. THE LOT WAS SUBJECT TO ENDOTOXIN TESTING AND RESULTS WERE ACCEPTABLE. RMI ENDOTOXIN TESTING CONSISTS OF USING THE ORGANISM E-COLI AS THE POSITIVE CONTROL, WHICH IS THE SAME ORGANISM REPORTED IN THE INFECTIONS. THE NEEDLES TESTED WERE ALL NEGATIVE FOR PYROGENS (B)(4). THE LOT WAS STERILIZED AS PART OF RMI STERILIZATION LOAD #(B)(4). THE STERILIZATION LOAD DOCUMENTATION WAS REVIEWED AND NO ABNORMALITIES WERE FOUND THAT COULD HAVE CONTRIBUTED TO THE INFECTIONS REPORTED. THE BI'S INCLUDED IN THE STERILIZATION LOAD WERE NEGATIVE FOR GROWTH. THE PRODUCT MET ALL PHYSICAL AND MICROBIOLOGICAL SPECIFICATIONS PRIOR TO RELEASE. THE INFORMATION PROVIDED BY THE FACILITY INDICATES THAT NOT ALL 4 OF THE PATIENTS RECEIVED BOTH PRE- AND POST-OPERATIVE ANTIBIOTICS, WHICH IS STANDARD PREVENTATIVE TREATMENT FOR THIS TYPE OF PROCEDURE. INFECTIONS OF THE PROSTATE ARE VERY COMMON WITH THIS TYPE OF PROCEDURE AND PREVENTATIVE PRACTICES ARE STRONGLY RECOMMENDED BY THE INDUSTRY TO REDUCE AND PREVENT THESE OCCURRENCES IN PATIENTS. THE INVESTIGATION, TESTING PERFORMED ON THE RETURNED NEEDLES, MANUFACTURING AND STERILIZATION REVIEW OF THE NEEDLE LOT IN QUESTION DO NOT INDICATE THAT THE RMI DEVICE WAS THE CAUSE OF THE INFECTIONS REPORTED IN THIS PATIENT.

    Description of Event or Problem · 1

    CLINICAL DIRECTOR AT FACILITY CONTACTED RMI ON (B)(6) 2010, TO REPORT PATIENT INFECTION (UROLOGICAL PROSTITIS [E. COLI INFECTION OF THE PROSTATE]) AFTER USE OF THE RMI (B)(4) AUTOMATIC CUTTING NEEDLE (PROSTATE BIOPSY NEEDLE; LOT #101824) DURING A PROSTATE BIOPSY PERFORMED WITH THE TRUS MAGNUM GUN. (NOTE: INFECTIONS WERE REPORTED FOR FOUR PATIENTS TOTAL FROM THE SAME FACILITY, USING (B)(4) NEEDLES FROM THE SAME LOT.) PATIENT #(B)(6) WAS GIVEN NO PRE-OPERATIVE ANTIBIOTIC AND WAS GIVEN THE ANTIBIOTIC CIPRO POST-UP. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2010, AND DIAGNOSED WITH E COLI AFTER URINE AND BLOOD CULTURES. THE FACILITY CONTACT ALSO STATED THAT 12 - 24 CORE SAMPLES WERE TAKEN DURING THE BIOPSY PROCEDURES OF EACH OF THE FOUR AFFECTED PATIENTS. RMI REQUESTED ADDITIONAL INFORMATION FROM THE CONTACT AT THE FACILITY REGARDING THEIR CLEANING PROCEDURES FOR THE BIOPSY GUN. THE CUSTOMER RESPONDED VIA E-MAIL, DATED (B)(6) 2010, STATING THAT THEIR "POLICY FOR CLEANING TRUS MAGNUM GUN IS AS FOLLOWS: GUN IS INITIALLY CLEANED WITH CAVI-WIPE. THEN POLICY IS TO FOLLOW BARD CLEANING INSTRUCTIONS WITH SONIC. AFTER FIRST INFECTION, WE CHANGED TO AUTOCLAVING UNIT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAC-1820MLL AUTOMATIC CUTTING NEEDLE KNW REMINGTON MEDICAL, INC. NAC-1820MLL 101824

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O BARD TRUS MAGNUM GUN