BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH

    MDR report key: 24047011 · Received January 12, 2026

    Report

    Report Number
    1911916-2025-00838
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    December 19, 2025
    Report Date
    December 25, 2025
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FOZ
    UDI-DI
    00382903065462
    PMA / PMN Number
    K003553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTS WERE RECEIVED OF FLUSHES LACKING THE WHITE TIP CAP. TO SUPPORT THE INVESTIGATION, ONE SAMPLE IN THE PACKAGING FLOW WRAP RECEIVED IN A PLASTIC BAG AND THREE PHOTOGRAPHS WERE PROVIDED FOR EVALUATION BY THE QUALITY TEAM. THE RETURNED UNIT IS MISSING THE SYRINGE BARREL TIP CAP, AND THE PHOTOGRAPHS PROVIDED DEPICT THE SAME UNIT. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS CONDITION COULD OCCUR IF A JAM OCCURRED DURING THE TIP CAP ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 306546, LOT 5233237. THE REVIEW IDENTIFIED NO QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION, AND THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS CONTROLS AND FINAL INSPECTIONS MET SPECIFICATION REQUIREMENTS. THE SAMPLE WILL BE SHARED WITH ASSOCIATES FOR AWARENESS. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND ANALYSIS OF THE RETURNED SAMPLE, THE CUSTOMER REPORTED CONDITION IS CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 10ML REG PR SALINE 10ML FILL TIP CAP WAS MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 306546 BATCH # 5233237. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. INJURIES OR ADVERSE EVENT: NO. ITEM: 306546. QUANTITY AFFECTED: 1EA. SERIAL/LOT NUMBER: (B)(6). PO: (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. ARE SAMPLES POTENTIALLY CONTAMINATED OR BIOHAZARD? NO. REPORTED ISSUE: WE HAVE BEEN RECEIVING MULTIPLE FLUSHES WITHOUT THE WHITE CAP ON THEM CUSTOMER DISPOSITION REQUEST: REPLACEMENT. ADDITIONAL INFORMATION: DATE OF EVENT: 12-19-2025. TOTAL OCCURRENCES: ONLY RECEIVED 1 EACH NURSE STATED THEY HAD FOUND THREE TO FOUR WITHOUT CAPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108001 BD POSIFLUSH CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM FOZ BD MEDICAL (BD WEST) MEDICAL SURGICAL 5233237 00382903065462

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown