BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICINAL LEECH

    MDR report key: 21182696 · Received January 17, 2025

    Report

    Report Number
    2419564-2025-00002
    Event Type
    Malfunction
    Date Received
    January 17, 2025
    Date of Event
    December 17, 2024
    Report Date
    July 25, 2025
    Manufacturer
    LEECHES USA LTD.
    Product Code
    NRN
    UDI-DI
    00861028000300
    PMA / PMN Number
    K040187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRIOR TO RELEASE FOR SALE, THE LEECHES WERE SUBJECT TO MICROBIAL TESTING AND FOUND CONFORMING TO SPECIFICATIONS. SUBSEQUENTLY THE LEECHES CAME INTO CONTACT WITH BOTTLED DISTILLED WATER ONLY UNTIL THEY WERE DELIVERED TO THE HEALTHCARE FACILITY. MANUFACTURING RECORDS (DHR) WERE REVIEWED AND NO NONCONFORMANCES WERE IDENTIFIED. IT IS UNCLEAR WHETHER THE CONTAMINATION DETECTED BY THE HEALTHCARE FACILITY WAS PRESENT IN THE SHIPPING WATER OR WHETHER THE WATER WAS CONTAMINATED DURING THE PROCESS OF SAMPLING OR CULTURING AT THE HEALTHCARE FACILITY. IN ADDITION, IT MUST BE NOTED THAT IN ACCORDANCE WITH DEVICE INSTRUCTIONS FOR USE LEECHES MUST BE REMOVED FROM SHIPPING WATER AND PLACED IN A CONTAINER OF CLEAN WATER IMMEDIATELY UPON RECEIPT. ALSO, PRIOR TO USE ON A PATIENT, LEECHES MUST BE RINSED AND MAINTAINED IN CLEAN WATER FOR NO LONGER THAN FOUR HOURS IN ORDER TO PREVENT UNDUE MICROBIAL CONTAMINATION OF THE PRODUCT AND THE WATER IT IS IN CONTACT WITH. THE RESULTS OBTAINED BY TESTING SHIPPING WATER CANNOT BE CONSIDERED REPRESENTATIVE OF THE PRODUCT DURING CLINICAL USE. PATIENT INFECTION BY RHODOCOCCUS ERYTHROPOLIS OR OTHER RHODOCOCCUS STRAINS HAS NOT BEEN LINKED TO LEECHES IN LITERATURE AND IS RARELY REPORTED WITH REGARD TO OTHER ROUTES OF TRANSMISSION. THE SENSITIVITY RATE OF RHODOCOCCUS ERYTHROPOLIS TO CIPROFLAXIN, ONE OF THE ANTIBIOTICS RECOMMENDED IN THE LEECH USER MANUAL FOR PROPHYLACTIC USE, IS EQUAL TO OR GREATER THAN 80%. ANTIBIOTIC SUSCEPTIBILITY TESTING PERFORMED BY THE HEALTHCARE FACILITY ON THE CONTAMINATED SAMPLES SHOWED THE MORGANELLA MORGANII AND OCHTROBACTRUM SPECIES TO BE SUSCEPTIBLE TO BOTH CIPROFLAXIN AND TRIMOTHEPRIM/SULFAMETHOXAZOLE. THUS, ROUTINE PROPHYLACTIC ANTIBIOTIC TREATMENT AS RECOMMENDED BY PRODUCT LABELING IS ADVISABLE TO MITIGATE ANY REMAINING RISK OF INFECTION. AFTER ISSUING THE COMPLAINT THE HEALTHCARE FACILITY DESTROYED ALL LEECHES. TESTING OF THE LEECHES THEMSELVES WAS NO LONGER POSSIBLE. INVESTIGATION IS IN PROGRESS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    SINCE THE ALLEGEDLY AFFECTED LOT HAD BEEN SOLD OUT AT THE TIME THE COMPLAINT WAS RECEIVED AND THE HEALTHCARE FACILITY HAD DISCARDED THE DEVICES IT RECEIVED, A DIFFERENT LOT WAS TESTED FOR RHODOCOCCUS BY THE MANUFACTURER. NO RHODOCOCCUS WAS DETECTED. IT HAS NOT BEEN POSSIBLE TO CONFIRM THE PROBLEM REPORTED BY THE HEALTHCARE FACILITY. REVIEW OF DOCUMENTS PROVIDED BY THE HEALTHCARE FACILITY, WHEN MATCHED AGAINST THE SHIPPING RECORDS, REVEALED THAT THE LOT NUMBER INITIALLY REPORTED BY THE HEALTHCARE FACILITY WAS NOT CORRECT. THE CORRECT LOT NUMBER IS 24/922/B. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THE COMPLAINT WILL BE REOPENED. FIELDS B4, D4, G3, G6, H2, H6, AND H11 WERE MODIFIED IN THIS SUPPLEMENT REPORT.

    Description of Event or Problem · 0

    DURING ROUTINE CULTURE PERFORMED OF LEECH SHIPPING WATER UPON DELIVERY BY THE HEALTHCARE FACILITY PHARMACY, RHODOCOCCUS ERYTHROPOLIS, MORGANELLA MORGANII AND OCHROBACTRUM SPECIES WERE DETECTED. ALL LEECHES IN THE SHIPMENT WERE DESTROYED. THEY WERE NOT USED ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876420 MEDICINAL LEECH MEDICINAL LEECH NRN LEECHES USA LTD. LE 2000 24/922/B 00861028000300

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown