Deltaven Fast Flash 3811473Recalls & reported problems
Delta Med SPA · Safety IV catheter in PUR with closed system, dual entry with two needleless valves · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08032248381148), received between Oct 15, 2024 and Oct 15, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
- Protective Measures Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2024Protective Measures Problem; Protective Measures Problem
I WAS PLACING AN INTRAVENOUS LINE (IV) FOR MY POSITRON EMISSION TOMOGRAPHY (PET) RUBIDIUM PATIENT AND WHEN I GOT BLOOD RETURN AND RETRACTED THE NEEDLE BACK, THE NEEDLE WAS STILL EXPOSED AND DID NOT LOCK WITH THE SAFETY FEATURE, LEAVING THE NEEDLE EXPOSED, ALMOST POKING MYSELF. HIGH SAFETY RISK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20450747 ↗MalfunctionOct 15, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE SAFETY HUB HAS A CRACK IN IT AND WAS LEAKING. I SWITCHED OUT 3 DIFFERENT (INCLUDING THE ONE THAT CAME WITH THE INTRAVENOUS LINE (IV) SET) MICROCLAVE CONNECTORS., BUT THE LEAKING CONTINUED. SINCE I WAS GOING TO BE INJECTING A RADIOACTIVE DOSE, I COULD NOT USE THIS IV BECAUSE I DID NOT WANT RADIOACTIVITY TO LEAK OUR THE IV. SO I HAD TO START ANOTHER IV ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20450744 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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