BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CALIBRATED DISPOSABLE INOCULATING LOOPS, BLUE 10¿L (20X50 LOOPS)

    MDR report key: 18830128 · Received March 4, 2024

    Report

    Report Number
    1119779-2024-00169
    Event Type
    Malfunction
    Date Received
    March 4, 2024
    Date of Event
    September 25, 2023
    Report Date
    September 13, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LXG
    UDI-DI
    00382902202172
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS MEMO SERVES TO SUMMARIZE FINDINGS ON YOUR RECENT COMPLAINT (B)(4) ON PRODUCT 220217 (LOOPS INOCULATING 50/TUBE 10 MICROLITER), LOT NUMBER 2301040, WHERE IT WAS OBSERVED THAT THE BOX WAS MISLABELED. EVENT DESCRIPTION: "CUSTOMER REPORTING MISLABELED BOX OF BLUE 10 UL LOOPS 220217 LOT 2301040." 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: THE COMPLAINT NOTES INDICATE THAT RETURNS WERE SENT AND RECEIVED BY BD. HOWEVER, NO RETURNS WERE DELIVERED BY THE RECEIVING TEAM. THE RETENTION SAMPLES WERE SATISFACTORY. EVALUATIONS RESULTS: BASED ON THE INVESTIGATION, NO DEFECT WAS OBSERVED. INVESTIGATION CONCLUSION: BASED ON THE EVALUATION OF THE INVESTIGATION, THE COMPLAINT COULD NOT BE CONFIRMED. NO FURTHER ACTION WILL BE TAKEN AS NO DEFECT WAS OBSERVED AND NO COMPLAINT TREND IS PRESENT ON THIS ISSUE. BD WILL CONTINUE TO MONITOR FOR TRENDING.

    Additional Manufacturer Narrative · 0

    D.1 COMMON DEVICE NAME: EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED AND PROMOTED FOR A SPECIFIC MEDICAL USE (B)(6). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN SPARKS, MD HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE SPARKS FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD CALIBRATED DISPOSABLE INOCULATING LOOPS, BLUE 10L (20X50 LOOPS) THERE WERE 10 MISLABELED BOXES. THERE WAS NO REPORT OF IMPACT TO THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD CALIBRATED DISPOSABLE INOCULATING LOOPS, BLUE 10L (20X50 LOOPS) THERE WERE 10 MISLABELED BOXES. THERE WAS NO REPORT OF IMPACT TO THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710767 BD CALIBRATED DISPOSABLE INOCULATING LOOPS, BLUE 10¿L (20X50 LOOPS) SEE H.10 LXG BECTON DICKINSON & CO. (SPARKS) 2301040 00382902202172

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown