SmartSite MV0420Recalls & reported problems
Yukon Medical, LLC · CareFusion 20mm SmartSite Vented Vial Access Device · Class 2
- 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 10885403228452), received between Nov 29, 2019 and Oct 21, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Leak/Splash1
- Manufacturing, Packaging or Shipping Problem1
- Protective Measures Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 21, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT SMART-SITE 20MM VENTED VIAL ACCESS DEVICE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: MV0420; BATCH NO: UNKNOWN. IT WAS REPORTED THAT WHILE ATTACHING THIS DEVICE TO OUR 20MM VIAL, THE DEVICE DID NOT PIERCE THE STOPPER, BUT INADVERTENTLY PUSHED THE STOPPER INTO THE VIAL.
Patient problems: No Patient Involvement
MAUDE report 10710185 ↗MalfunctionNov 29, 2019Manufacturing, Packaging or Shipping Problem; Protective Measures Problem
MULTIPLE VIALS OF BENDEKA BRAND OF BENDAMUSTINE 100 MG VIAL HAVE RUBBER VIAL STOPPERS THAT ARE TOO THICK AND RESISTANT TO PUNCTURE BY CTSD (CLOSED SYSTEM TRANSFER DEVICES) NOW REQUIRED BY USP 800. THE STOPPERS CAN DISLODGE AND BE FORCED INTO THE VIALS, RISKING EMPLOYEE EXPOSURE TO NIOSH LISTED HAZARDOUS MEDICATIONS AND RISKING PYROGENIC PARTICLE CONTAMINATION OF MEDICATIONS REACHING PTS. FDA SAFETY REPORT ID# (B)(4).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9397231 ↗
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- EXACTAMIX H938739Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall972 reports
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- EXACTAMIX H938737Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall607 reports
- EXACTAMIX H938724Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall513 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.