BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTAVEN SAFETY IV CATHETER

    MDR report key: 25149752 · Received May 12, 2026

    Report

    Report Number
    MW5188023
    Event Type
    Injury
    Date Received
    May 12, 2026
    Date of Event
    May 6, 2026
    Report Date
    May 7, 2026
    Manufacturer
    DELTA MED SPA
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IV CAP ON THE DELTAVEN SAFETY CATHETER OF PUR(POLYURETHANE) WITH CLOSED 20 GRAM PERIPHERAL PIV- PERIPHERAL INTRAVENOUS CATHETER WAS LOCATED ON LEFT HAND CAME OFF. PATIENT FOUND IN LARGE PUDDLE OF BLOOD COVERING ABDOMEN ~ 12 X 10" IN DIAMETER AND SOAKED THROUGH BLANKET, FLAT SHEET. AN 8X8" BLOOD SPOT WAS ALSO SEEN ON THE CHUX. STAFF MEMBER REPORTED THIS IS THE THIRD EVENT DURING THIS SHIFT. PT: 1888. DEVICE: 2907, 1250. REF: MW5188022, MW5188024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535511 DELTAVEN SAFETY IV CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ DELTA MED SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention DELTAVEN SAFETY IV CATHETER (PUR)-(B)(6) 2026