BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 20ML LL TIP CONV PAK

    MDR report key: 19974273 · Received August 13, 2024

    Report

    Report Number
    9610847-2024-00229
    Event Type
    Malfunction
    Date Received
    August 13, 2024
    Date of Event
    July 23, 2024
    Report Date
    September 17, 2024
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    00382903056170
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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#: 4064405 ,4064403 ,4033844.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE 1 VIDEO SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF BARREL CRACKED WAS CONFIRMED UPON INSPECTION OF THE SAMPLE. ANALYSIS OF THE SAMPLE SHOWED A CRACK LINE IN THE SYRINGE BARREL. BD WAS NOT ABLE TO DETERMINE THE CAUSE OF THE FAILURE WITHOUT EVALUATION OF A PHYSICAL 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 20ML LL TIP CONV PAK BARREL WAS CRACKED IT WAS REPORTED BY CUSTOMER THAT WE WOULD LIKE TO REPORT A SECOND INCIDENT WITH THESE BD305617 20ML LUER-LOCK TIP SYRINGES CRACKING. WE WERE UNABLE TO RECUPERATE THE FIRST SYRINGE. AFTER BATCHING, THEY ARE STORED IN FREEZER, THEN THAWED AND MOVED INTO FRIDGE. VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED WE WOULD LIKE TO REPORT A SECOND INCIDENT WITH THESE BD305617 20ML LUER-LOCK TIP SYRINGES CRACKING. WE WERE UNABLE TO RECUPERATE THE FIRST SYRINGE. AFTER BATCHING, THEY ARE STORED IN FREEZER, THEN THAWED AND MOVED INTO FRIDGE. CURRENT LOT NUMBERS ON HAND ARE: 4064405 EXP: 2029-02-28, 4064403 EXP:2029-02-28, 4033844 EXP: 2029-01-31 THANK YOU KINDLY FOR YOUR INVESTIGATION INTO A POTENTIAL QUALITY ISSUE WITH THE PRODUCT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1682535 BD SYRINGE 20ML LL TIP CONV PAK SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 4033844 00382903056170

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown