UNBRANDED 10-106Recalls & reported problems
Advance Medical Designs, Inc. · Decanter · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00848340000027), received between Jun 2, 2025 and Jun 2, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Insert” (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
- Difficult to Insert1
- Material Integrity Problem1
Patient problems
- Aseptic loosening1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 2, 2025Difficult to Insert; Material Integrity Problem
WE JUST RECENTLY PURCHASED THIS PRODUCT TO USE FOR REMOVING MEDICATION FROM GLASS VIALS ¿ IT IS SUPPOSED TO BE MORE ASEPTIC THAN REMOVING THE RUBBER STOPPER ON THE MEDICATION VIAL, HOPEFULLY HELPING US REDUCE RISK OF INFECTION. THE PRODUCT IS DIFFICULT TO USE. IT¿S VERY HARD TO INSERT IT INTO THE RUBBER VIAL STOPPER ¿ IT HAS A POINTY TIP, BUT IT¿S VERY HARD TO PIERCE THE RUBBER WITH IT. ALSO, IN THE PROCESS IT CORES OUT PIECES OF RUBBER, LEAVING RUBBER FLOATING IN THE MEDICATION.
Patient problems: Aseptic loosening
MAUDE report 22122783 ↗
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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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