Deltaven Fast Flash 3836773Recalls & reported problems
Delta Med SPA · Safety IV catheter in PUR with closed system, single entry · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08032248383678), received between Nov 17, 2025 and Jul 2, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).
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 Leak3
Patient problems
- Insufficient Information4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 2, 2026
LEAKING FROM THE PORT WHERE THE NEEDLE SEPARATES FROM THE CATHETER. I INSERTED IT LEAKS AND THEN I ASKED ANOTHER NURSE TO INSERT ANOTHER ONE STILL LEAKING WHEN WE FLUSHED. WE DECIDED TO LEAVE IT ON FOR A WHILE LIKE 15 MINS OR MORE AND FLUSHED IT AGAIN, NO LEAKING WAS NOTED. AFTER FLUSHING WITH NS [NORMAL SALINE] IT STARTED TO LEAK FROM THE WHITE PLASTIC PORT (PART THAT'S EXPOSED AFTER TAKING OUT THE NEEDLE). I PLACED ANOTHER IV USING ANOTHER 20 G AND ALSO LEAKED. BUT AFTER SOME TIME (FEW MINUTES) THEY BOTH STOPPED LEAKING. THE LEAKING WAS SORT OF SLOW "OOZE" AND NOT CONTINUOUS LEAK, AND IT HAPPENED AFTER FLUSHING
Patient problems: Insufficient Information
MAUDE report 25689824 ↗MalfunctionJun 16, 2026Fluid/Blood Leak
DESCRIBE THE EVENT OR PROBLEM: PLACED 20G PIV [PERIPHERAL IV] IN PATIENT IN BUT NOTED LEAKING ON NEEDLE PORTAL WHEN FLUSHED. PIV REMOVED.
Patient problems: Insufficient Information
MAUDE report 25516872 ↗MalfunctionApr 28, 2026Fluid/Blood Leak
DESCRIBE THE EVENT OR PROBLEM: WHEN THE PERIPHERAL IV WAS INSERTED IN THE PATIENT'S VEIN, BLOOD LEAKED BACK FROM THE PORT. SITE WAS CLEANED AND BLEEDING DID NOT CONTINUE AND IV LINE WAS ABLE TO BE USED. NO OTHER ISSUES.
Patient problems: Insufficient Information
MAUDE report 25012321 ↗MalfunctionNov 17, 2025Fluid/Blood Leak; Fluid/Blood Leak
DESCRIBE THE EVENT OR PROBLEM: RN PLACED IV WITH US [ULTRASOUND] GUIDANCE. RN HAD GOOD RETURN DOWN THE LINE, FLUSHED WITH NS [NORMAL SALINE], NS AND BLOOD LEAKED OUT OF THE WHITE PERMANENT "CAP" AT THE BASE OF THE "BUTTERFLY." RN THEN TRIED TO PULL BACK GENTLY TO ASPIRATE BLOOD BACK IN THE LINE, AUDIBLE "WHISTLE" OF AIR HEARD, RN SAW AIR FILL UP THE EXTENSION LINE BACK FROM THE PERMANENT "WHITE CAP" AT BASE OF THE BUTTERFLY TOWARD THE SYRINGE. IMMEDIATELY REMOVED DEFECTIVE IV PRODUCT FROM THE PT TO AVOID FLUSHING AIR TOWARD THE PT. CONCERN, RISK OF AIR INJECTION TOWARD PT. THERAPIES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT: NOT KNOWN.
Patient problems: Insufficient Information
MAUDE report 23568389 ↗
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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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