BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 30ML LL TIP CONV PAK

    MDR report key: 20455721 · Received October 15, 2024

    Report

    Report Number
    9610847-2024-00309
    Event Type
    Malfunction
    Date Received
    October 15, 2024
    Date of Event
    August 29, 2024
    Report Date
    December 30, 2024
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    00382903056187
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. BATCH#: 4171131, 4156993, 4148345, 4086289, 4180176.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE 7 PHOTOS SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF SCALE MARKING ISSUE WAS NOT CONFIRMED UPON INSPECTION OF THE SAMPLES. ANALYSIS OF THE SAMPLE SHOWED THAT THE SYRINGES ARE PACKAGED IN SINGLE PACKAGING BLISTER AND THE SCALE MARKING IS ACCORDING TO PRODUCT SPECIFICATION. BD COULD NOT DETERMINE A MANUFACTURING RELATED ROOT CAUSE SINCE THE REPORTED DEFECT WAS NOT CONFIRMED DURING THE EVALUATION OF THE SAMPLE. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 30ML LL TIP CONV PAK SCALE MARKING ISSUE. IT WAS REPORTED BY CUSTOMER THAT LABELLING ISSUE. ISSUE - LABELLING ISSUE. ITEM: 305618. SHOWN ON OUR WEBSITE WITH OZ AND ML GRADUATION MARKS, BUT OUR CURRENT STOCK HAS THE SYRINGES WITHOUT. IT¿S OKAY IF THERE WAS A CHANGE, WE WOULD JUST LIKE TO KNOW IF THIS SHOULD BE EXPECTED ON ALL FUTURE SHIPMENTS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33011 BD SYRINGE 30ML LL TIP CONV PAK SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 4171131 00382903056187

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown