115 in (292 cm) Q2 MultiPort IV administration Set, 10 drops/ml 9527BRecalls & reported problems
Quest Medical Inc · Class 2
Data updated Oct 18, 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 00634624952720), received between Feb 1, 2017 and Feb 1, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment Of Device Component” (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 18, 2026.
Most reported problems
Device problems
- Detachment Of Device Component1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 1, 2017Detachment Of Device Component
THE HOSPITAL REPORTED AN ISSUE WITH THE INTRAVENOUS ADMINISTRATION SET. THE NURSE REPORTED THAT THE SET WAS CONNECTED TO A PATIENT FOR CHEMOTHERAPY, BUT ON DAY 3 AS THE NURSE WAS DISCONNECTING THE LINE THE BLUE PORT DETACHED FROM THE SET'S MANIFOLD. THERE WAS NO PATIENT INFORMATION PROVIDED. THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6292852 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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