BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK

    MDR report key: 21032706 · Received December 29, 2024

    Report

    Report Number
    1213809-2024-00997
    Event Type
    Malfunction
    Date Received
    December 29, 2024
    Date of Event
    December 3, 2024
    Report Date
    February 11, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096054
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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.

    Additional Manufacturer Narrative · 0

    TWO SAMPLES AND THREE PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. BOTH SAMPLES WERE RECEIVED SEALED WITH ALL APPLICABLE PRODUCT INFORMATION ON THE TOP WEB, AND BOTH SAMPLES HAVE DAMAGE TO THE TRAY WITH ONE CAUSING THE SEAL TO POP OPEN. ONE OF THE PHOTOS SHOWS THE TOP WEB OF A PACKAGE WITH ALL APPLICABLE PRODUCT INFORMATION, AND THE OTHER TWO PHOTOS SHOW DAMAGE TO THE TRAYS AS DESCRIBED ABOVE. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE PACKAGE DAMAGED AND SEAL INTEGRITY DEFECT IS ASSOCIATED WITH THE BOX HANDLING PROCESS. THESE CONDITIONS ARE OCCURRING BELOW THEIR EXPECTED FREQUENCY SO, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 4110189. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    MATERIAL # 309605, BATCH # 4110189. IT WAS REPORTED THAT THE BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK PACKAGE WAS DAMAGED / DEFECTIVE / OTHER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. DURING GATHERING SUPPLIES FOR COMPOUNDED LOT #20241203-6D4058 TWO TRAYS WERE FOUND DAMAGED. THE TRAYS WERE NOT OPENED OR USED. THE SHIPPER WAS NOT DAMAGED. THE SYRINGES ARE AVAILABLE FOR RETURN. (B)(6) 2024 PCC-24-050 STERILE SYRINGE TRAY 10ML 309605 / EXPIRY 3-31-2029 LOT #4110189 DAMAGED TRAYS - 2 TRAYS (40 SYRINGES).

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2494907 BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4110189 30382903096054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown