BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML SALINE POSIFLUSH SAFESCRUB

    MDR report key: 23950393 · Received January 2, 2026

    Report

    Report Number
    1911916-2025-00826
    Event Type
    Malfunction
    Date Received
    January 2, 2026
    Date of Event
    December 12, 2025
    Report Date
    January 9, 2026
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    QTI
    UDI-DI
    00382903031917
    PMA / PMN Number
    K213955
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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

    PR (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED BLACK MATTER WAS FOUND IN ONE OF THE SYRINGES. TO SUPPORT THE INVESTIGATION, OUR QUALITY TEAM RECEIVED TWO EMPTY SYRINGES WITHOUT FLOW WRAP PACKAGING OR TIP CAPS FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS, IMPERFECTIONS, OR FOREIGN MATTER WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 303191, LOT 5162275. THE REVIEW IDENTIFIED NO QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THERE WERE NO RELATED QUALITY NOTIFICATIONS, AND ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION, INCLUDING ANALYSIS OF THE RETURNED SAMPLES, THE CUSTOMERS REPORTED CONDITION COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 10ML SALINE POSIFLUSH SAFESCRUB CONTAINED FOREIGN MATTER. VERBATIM: THE CUSTOMER HAS FOUND BLACK MATTER IN ONE OF THE SYRINGES. 2 FLUSHES WERE FOUND WITH PARTICLES INSIDE THE FLUSH.

    Description of Event or Problem · 0

    NO ADVERSE EVENTS OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12198 BD SYRINGE 10ML SALINE POSIFLUSH SAFESCRUB SALINE VASCULAR ACCESS FLUSH WITH INTEGRATED ALCOHOL DISINFECTANT DEVICE QTI BD MEDICAL (BD WEST) MEDICAL SURGICAL 5162275 00382903031917

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other