BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSIFLUSH

    MDR report key: 24885368 · Received April 15, 2026

    Report

    Report Number
    1911916-2026-00171
    Event Type
    Malfunction
    Date Received
    April 15, 2026
    Date of Event
    April 1, 2026
    Report Date
    April 6, 2026
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    00382903065479
    PMA / PMN Number
    K003553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G.4. ADDITIONAL 510K: K161552 B3. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD. DEVICE EVALUATION A BLACK, MOLD LIKE SUBSTANCE WAS REPORTED TO BE PRESENT WITHIN THE SYRINGE TIP AND TIP CAP. IN SUPPORT OF THE INVESTIGATION, THE QUALITY TEAM RECEIVED FIFTY NINE SAMPLES AND THREE PHOTOGRAPHS FOR EVALUATION. OF THE SAMPLES RECEIVED, FIFTY EIGHT WERE CONTAINED IN SEALED FLOW-WRAP PACKAGING, WHILE ONE SAMPLE WAS RECEIVED WITHOUT A TIP CAP OR PACKAGING FLOW WRAP. VISUAL INSPECTION IDENTIFIED DAMAGE TO THE SYRINGE BARREL LUER ON THE UNPACKAGED SAMPLE. NO ADDITIONAL DEFECTS, IMPERFECTIONS, OR FOREIGN MATERIAL WERE OBSERVED. THE REMAINING FIFTY EIGHT SAMPLES EXHIBITED NO DEFECTS OR IMPERFECTIONS. THE THREE PHOTOGRAPHS PROVIDED CORRESPOND TO THE SAMPLE EXHIBITING LUER DAMAGE. A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR MATERIAL NUMBER 306547, LOT 5356693. THE REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DURING MANUFACTURING THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION, AND NO RELATED QUALITY NOTIFICATIONS WERE IDENTIFIED. ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. VERIFICATION OF THE MOLDING AND FILL ROOM PROCESSES CONFIRMED PROPER RAIL AND CONVEYOR ALIGNMENT AND NORMAL PRODUCT FLOW. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND ANALYSIS OF THE RETURNED SAMPLE, THE CUSTOMER-REPORTED CONDITION OF LUER DAMAGE IS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED, "BD NS PRE-FILLED FLUSH SYRINGE THAT HAS A SUBSTANCE OF SOME SORT FLOATING AROUND IN IT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946318 POSIFLUSH SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 5356693 00382903065479

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown