BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK

    MDR report key: 23432705 · Received October 30, 2025

    Report

    Report Number
    1213809-2025-00687
    Event Type
    Malfunction
    Date Received
    October 30, 2025
    Date of Event
    October 8, 2025
    Report Date
    December 5, 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

    (B)(4) - SUPPLEMENTAL MDR - BARREL CRACKED. A PHOTO AND VIDEO OF A 10 ML LUER-LOK SYRINGE (PART NUMBER 309605) WERE REVIEWED. THE PHOTO SHOWS MINOR VOIDS IN THE PRINT ON TWO GRADUATION LINES; HOWEVER, MORE THAN 50% OF THE MARKINGS ARE INTACT, MEETING SPECIFICATIONS. THE VIDEO DEPICTS A LOOSE SYRINGE FILLED WITH AN UNKNOWN CLEAR FLUID, CAPPED WITH AN UNIDENTIFIED WHITE TIP, AND AN AIR BUBBLE VISIBLE NEAR THE STOPPER. NO REPORTED DEFECTS SUCH AS CRACKS, MISSING OR FADED MARKINGS, OR FOREIGN PARTICLES WERE OBSERVED IN EITHER THE PHOTO OR VIDEO. THE SYRINGE CONDITION APPEARS ACCEPTABLE PER PRODUCT SPECIFICATIONS; HOWEVER, A PHYSICAL SAMPLE IS REQUIRED FOR A THOROUGH EVALUATION AND ROOT CAUSE ANALYSIS. ADDITIONALLY, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR THE PROVIDED LOT NUMBERS 5121433 AND 5211788. THE REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING 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 IN TREND REPORTS AND MONITORED MONTHLY, AND OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA TO IDENTIFY EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    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, BATCH#: UNKNOWN (PROVIDED LOT: 5121433, 5211788). RCC RECEIVED A COMPLAINT VIA EMAIL. DURING COMPOUNDING OF LOT#: 20251008-96D150 THE FOLLOWING SYRINGE ISSUES WERE NOTICED, 1 CRACKED SYRINGE - AVAILABLE FOR RETURN. 1 SYRINGE WITH NO MARKINGS ¿ NOT AVAILABLE FOR RETURN. 1 SYRINGE WITH FADED MARKINGS¿ NOT AVAILABLE FOR RETURN. 1 SYRINGE WILL ALMOST NO MARKINGS¿ NOT AVAILABLE FOR RETURN. 2 WITH FOREIGN PARTICULATE ON THE RUBBER STOPPER (DOES NOT APPEAR TO MOVE) ¿ NOT AVAILABLE FOR RETURN. TWO DIFFERENT LOT# WERE USED IN COMPOUNDING SO I¿M UNSURE THE LOT# IN WHICH THE COMPLAINTS ARE FROM. DATE OF THE COMPLAINT IS ON (B)(6) 2025. NO PATIENTS ARE INVOLVED. ON (B)(6) 2025: PCC-25-135, STERILE SYRINGE TRAY 10ML, 309605 EXPIRY 4/30/2309 AND 6-30-2030 5121433, 5211788, SYRINGE MARKINGS, MISSING MARKINGS, FADED MARKINGS, 3. ON (B)(6) 2025: PCC-25-135, STERILE SYRINGE TRAY 10ML, 309605, EXPIRY 4/30/2309 AND 6-30-2030 5121433, 5211788, FOREIGN PARTICULATE, SITTING ON THE STOPPER 2. ON (B)(6) 2025: PCC-25-135, STERILE SYRINGE TRAY 10ML, 309605, EXPIRY 4/30/2309 AND 6-30-2030 5121433, 5211788, CRACKED SYRINGE, BARREL CRACKED, 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1906175 BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 30382903096054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown