BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML REG PR SALINE 10ML FILL

    MDR report key: 22553979 · Received July 21, 2025

    Report

    Report Number
    1911916-2025-00531
    Event Type
    Malfunction
    Date Received
    July 21, 2025
    Date of Event
    July 3, 2025
    Report Date
    July 22, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903065462
    PMA / PMN Number
    K003553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION A REPORT WAS RECEIVED INDICATING THE PRESENCE OF A BROWN ADHESIVE-LIKE SUBSTANCE ON THE TIPS OF FLUSH SYRINGES. TO SUPPORT THE INVESTIGATION, TWO SEALED FLOW-WRAPPED SAMPLES AND ONE PHOTOGRAPH WERE SUBMITTED FOR EVALUATION BY THE QUALITY TEAM. UPON VISUAL INSPECTION, THE SYRINGE TIP CAPS EXHIBITED A BROWN-COLORED RESIDUE THAT APPEARED TO BE SURFACE-LEVEL AND NOT EMBEDDED IN THE MATERIAL. THE PHOTOGRAPH PROVIDED CONFIRMED THE CONDITION OBSERVED IN THE RETURNED SAMPLES. NO ADDITIONAL DEFECTS OR ABNORMALITIES WERE IDENTIFIED. THIS CONDITION MAY OCCUR IF RESIDUES FROM EQUIPMENT LUBRICANTS ARE NOT FULLY REMOVED FOLLOWING EQUIPMENT MAINTENANCE OR REPAIR ACTIVITIES. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR MATERIAL NUMBER 306546, LOT 5063053. THE REVIEW FOUND NO QUALITY ISSUES OR DEVIATIONS DURING THE PRODUCTION OF THIS LOT THAT COULD BE LINKED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE IDENTIFIED, AND ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. THE RETURNED SAMPLES WILL BE SHARED WITH PRODUCTION ASSOCIATES TO RAISE AWARENESS. AS OF THIS REPORT, NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FOR THIS LOT. BASED ON THE INVESTIGATION AND ANALYSIS OF THE RETURNED SAMPLES, THE CUSTOMER-REPORTED CONDITION HAS BEEN CONFIRMED.

    Description of Event or Problem · 0

    DESCRIPTION: SOME OF THE FLUSH SYRINGES HAVE SOME KIND OF BROWN GLUE ON THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2037375 SYRINGE 10ML REG PR SALINE 10ML FILL CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BECTON DICKINSON 5063053 00382903065462

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown