BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH

    MDR report key: 24046684 · Received January 12, 2026

    Report

    Report Number
    1911916-2026-00004
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    November 27, 2025
    Report Date
    January 20, 2026
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FOZ
    UDI-DI
    00382903065479
    PMA / PMN Number
    K003553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: (H) ATTACHED MEDSUN. INVESTIGATION RESULTS: BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THE PRODUCT AND SYMPTOM. WITH NO ACTUAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL BARREL / FLANGE WAS DAMAGED. MATERIAL#: 306547, BATCH#: 5162313. RCC RECEIVED A COMPLAINT VIA EMAIL. THIS NURSE WAS GIVING A PULSE FLUSH TO A CENTRAL LINE, AND THE FLUSH PLASTIC PIECES BROKE OFF AND CUT THIS NURSES FINGER. CUT ON FINGER IS SMALL AND ONLY REQUIRED FIRST AID OF CLEANSING AND BAND AID. THE CUT LOOKS GOOD TODAY, NO S/S [SIGNS/SYMPTOMS] OF INFECTION AND WOUND IS HEALING. NURSE WAS SQUEEZING A FLUSH SYRINGE AND WHILE PULSATILE FLUSHING THE FLANGE ON THE FLUSH SYRINGE BROKE AND THAT IS WHAT CUT HIS FINGER. PRODUCT#: 306547, LOT#: 5162313.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108307 BD POSIFLUSH CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ BD MEDICAL (BD WEST) MEDICAL SURGICAL 5162313 00382903065479

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male