SmartSite MV0513Recalls & reported problems
Yukon Medical, LLC · CareFusion SmartSite VialShield 13mm Closed 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 10885403228100), received between Mar 23, 2022 and Jul 29, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Backflow” (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
- Backflow1
- Contamination1
- Defective Component1
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.
MalfunctionJul 29, 2022Contamination; Contamination
IT WAS REPORTED WHILE USING BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE, 13 MM THE STOPPER FELL INTO THE VIAL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE RUBBER STOPPER WAS PUSHED OUT WHEN THE ADAPTER WAS INSERTED AND FELL INTO THE BOTTLE. THE ADAPTER WAS INSERTED STRAIGHT, IN THE CENTER, AND WITH A SLIGHT TWISTING MOTION INTO THE RUBBER MEMBRANE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15135964 ↗MalfunctionMar 23, 2022Backflow; Defective Component; Backflow; Defective Component
IT WAS REPORTED BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE, 13 MM WAS DAMAGED AND HAD BACKFLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE BCG STARTS TO GO IN VIA THE CATHETER AND THEN IT STOPS AND STARTS BACKFLOWING BACK INTO THE SODIUM CHLORIDE BOTTLE ON US... ONE OF THE NURSES WHO REPORTED THE FLOW CONCERNS ALSO MENTIONED DIFFICULTY SEATING THE VIALSHIELD ON THE NSS VIAL. SHE STATED THAT SHE HAS OBSERVED THAT THE PLASTIC INSERTION TIP SOMETIMES APPEARS TO BE BENT AFTER BEING PUSHED INTO THE NSS VIAL."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13865236 ↗
Other Set, i.V. Fluid transfer devices
- EXACTAMIX H938740Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall1,350 reports
- EXACTAMIX H938738Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall1,180 reports
- EXACTAMIX H938739Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall972 reports
- EXACTAMIX H938741Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall710 reports
- EXACTAMIX H938737Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall607 reports
- EXACTAMIX H938724Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall513 reports
- EXACTAMIX H938173Baxter Healthcare Corporation · Set, i.V. Fluid transfer2 recalls260 reports
- EXACTAMIX H938176Baxter Healthcare Corporation · Set, i.V. Fluid transfer2 recalls232 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.