BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK

    MDR report key: 23475682 · Received November 5, 2025

    Report

    Report Number
    1213809-2025-00700
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    October 3, 2025
    Report Date
    November 20, 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
    NC, 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

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THAT SOME SYRINGES EXHIBITED CRACKS. TO SUPPORT THE INVESTIGATION, TWO SAMPLES OF 10 ML LUER-LOK SYRINGES WERE RECEIVED FOR EVALUATION BY THE QUALITY TEAM. BOTH SAMPLES ARRIVED LOOSE AND SHOWED CRACKS IN THE BARREL¿ONE MEASURING APPROXIMATELY 1¼ INCHES IN LENGTH AND THE OTHER 1½ INCHES. THIS CONDITION IS NON-CONFORMING TO PRODUCT SPECIFICATIONS AND APPEARS TO BE ASSOCIATED WITH THE ASSEMBLY PROCESS. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED FOR MATERIAL NUMBER 309605, LOT 5241727. THE REVIEW CONFIRMED THAT ALL VISUAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH REQUIREMENTS, AND NO QUALITY NOTIFICATIONS WERE IDENTIFIED RELATED TO THE REPORTED CONDITION. THE LOT WAS INSPECTED AND ACCEPTED BASED ON THE INSPECTION CONTROL PLAN, APPROVED FOR SHIPMENT, AND DEEMED COMPLIANT WITH PRODUCT SPECIFICATION REQUIREMENTS. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK BARREL CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #309605 LOT #5241727. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. CUSTOMER STATES THAT THEY HAD SOME OF THE 10ML LUERLOCK SYRINGES CRACK. CUSTOMER HAS PRODUCT TO RETURN IF NEEDED. CUSTOMER DID NOT HAVE THE PRODUCT NUMBER OR THE CERTAIN LOT NUMBER BUT THEY DID HAVE THE LOT NUMBER THAT THEY HAVE ONSITE (NOT SURE IF IT'S THE SAME LOT THAT CRACKED). LOT NUMBER 5241727,309605. ADDITIONAL INFORMATION PROVIDED: TO FOLLOW UP, WE HAD MORE CRACKING. I WAS ALSO INFORMED BY MY TECH THAT THEY HAVE BEEN FINDING THEM CRACKED BEFORE THEY EVEN USE THEM, IT IS USUALLY 1-2 FROM EACH BOX OF THE 20 SYRINGES. NEW LOT NUMBER: 5260078. ADDITIONAL INFORMATION RECEIVED ON 10/29/2025: MAJORITY WAS DURING USE HOWEVER ONE OF MY TECHS HAS MENTIONED THAT SHE SEEN SOME BROKEN PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2681734 BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5241727 30382903096054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown