BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H.11

    MDR report key: 22793464 · Received August 13, 2025

    Report

    Report Number
    1119779-2025-03160
    Event Type
    Malfunction
    Date Received
    August 13, 2025
    Date of Event
    June 14, 2023
    Report Date
    June 16, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LXG
    UDI-DI
    00382902202158
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    "D1: MEDICAL DEVICE BRAND NAME: BD CALIBRATED DISPOSABLE INOCULATING LOOPS, GREEN 1L (20X50 LOOPS). D2A: COMMON DEVICE NAME: EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED AND PROMOTED FOR A SPECIFIC MEDICAL USE. INVESTIGATION SUMMARY: COMPLAINT HISTORY REVIEW: A REVIEW OF PAST COMPLAINTS ON THIS PRODUCT OVER THE PAST 12 MONTHS DOES NOT INDICATE A TREND ON THIS ISSUE. DEVICE HISTORY RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD DOES NOT INDICATE ANY MANUFACTURING ISSUES. SAMPLE ANALYSIS: A REVIEW OF THE PHOTOS DID SHOW BLACK MATTER ON THE PLASTIC LOOP SHAFTS. NO RETURNS WERE AVAILABLE. THE RETENTION SAMPLES DID NOT EXHIBIT ANY DEFECTS. EVALUATIONS RESULTS: BASED ON THE INVESTIGATION, THE COMPLAINT WAS CONFIRMED ON PHOTOS. THERE IS NO SYSTEMIC FAILURE IN THE MANUFACTURING PROCESS AND THE RETENTION SAMPLES WERE SATISFACTORY. THERE IS NO COMPLAINT TREND ON THIS ISSUE. INVESTIGATION CONCLUSION: BASED ON THE EVALUATION OF THE INVESTIGATION, THE COMPLAINT WAS CONFIRMED. NO FURTHER ACTIONS WILL BE TAKEN AS NO CONFIRMED TREND HAS BEEN IDENTIFIED. THIS IS AN ISOLATED INCIDENT. BD WILL CONTINUE TO MONITOR FOR TRENDING." THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023-2025, UNDER CAPA 11910483.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD CALIBRATED DISPOSABLE INOCULATING LOOPS, GREEN 1 NL (20X50 LOOPS), THERE WAS MOLD CONTAMINATION WHICH LED TO FALSE RESULTS. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66133 SEE H.11 SEE H.11 LXG BECTON DICKINSON & CO. (SPARKS) 2209244 00382902202158

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown