BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSIFLUSH

    MDR report key: 24791909 · Received April 6, 2026

    Report

    Report Number
    1911916-2026-00152
    Event Type
    Malfunction
    Date Received
    April 6, 2026
    Date of Event
    March 25, 2026
    Report Date
    April 14, 2026
    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
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP. IT WAS REPORTED THERE WERE SOME BLACK DOTS. AS A PHYSICAL SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO SUPPORT THE INVESTIGATION, THE QUALITY TEAM REVIEWED A SINGLE PHOTOGRAPH PROVIDED BY THE CUSTOMER. THE IMAGE APPEARS TO SHOW A SYRINGE PLUNGER ROD AGAINST A WHITE BACKGROUND, WITH DARK COLORED SPECKS VISIBLE WITHIN THE PLUNGER ROD RIBS. NO ADDITIONAL DEFECTS OR IRREGULARITIES WERE OBSERVED IN THE PHOTOGRAPH. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 306546, LOT 5356778. THIS REVIEW DID NOT IDENTIFY ANY IN PROCESS OR FINAL INSPECTION NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION, AND NO RELATED QUALITY NOTIFICATIONS WERE FOUND. ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS MET APPLICABLE SPECIFICATION REQUIREMENTS. AT THE TIME OF THIS REVIEW, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE AVAILABLE INFORMATION AND PHOTOGRAPHIC ASSESSMENT, THE CONDITION REPORTED BY THE CUSTOMER IS CONSIDERED CONFIRMED. HOWEVER, WITHOUT EVALUATION OF AN ACTUAL PHYSICAL SAMPLE, A PROBABLE ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. G.4. ADDITIONAL 510K: K141311,K250884 B3. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED, BLACK DOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855626 POSIFLUSH SALINE, VASCULAR ACCESS FLUSH FOZ BD MEDICAL (BD WEST) MEDICAL SURGICAL 5356778 00382903065462

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown