BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL S/C 200

    MDR report key: 20464041 · Received October 16, 2024

    Report

    Report Number
    1213809-2024-00719
    Event Type
    Malfunction
    Date Received
    October 16, 2024
    Date of Event
    September 23, 2024
    Report Date
    December 3, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903029953
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP MDR FOR DEVICE EVALUATION. NINETY SAMPLES OF 10ML LUER-LOK SYRINGES FROM BATCH 4129250 WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. EIGHTEEN STRIPS OF FIVE SYRINGES IN SEALED PACKAGES WERE RECEIVED. THERE IS NO PERFORATION OBSERVED ON ANY OF THE STRIPS OF PACKAGES. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE UNCUT PACKAGES DEFECT IS RELATED TO THE PACKAGING 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 4129250. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    MATERIAL: 302995 BATCH#: 4129250 IT WAS REPORTED THAT THE BD SYRINGE 10ML LL S/C 200 PACKAGING WAS NOT PERFORATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. HOAG RECEIVED 1 BX B-D302995 AND THE SYRINGES ARE NOT PERFORATED. NEED TO REPORT QUALITY ISSUE AND HAVE RETURNED TO VENDOR. ITEM:302995 QUANTITY AFFECTED:1 BX SERIAL/LOT NUMBER: (B)(6). PO :(B)(6). ADDITIONAL INFO: THERE IS NO DATE OF INCIDENT, THE HOAG STAFF FOUND THEY COULD NOT SEPARATE THE PRODUCT TO STOCK THE SHELVES SO RETURNED TO STOREROOM. NO PATIENT WAS ADVERSELY AFFECTED. WILL YOU PROVIDE A CALL TAG SO WE CAN RETURN?

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2558119 BD SYRINGE 10ML LL S/C 200 PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4129250 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown