INTERLINK/DUO-VENT 2H7452Recalls & reported problems
Baxter International Inc. · Non-DEHP Secondary Medication Set with DUO-VENT Spike, Hanger, Lever Lock Cannula, Male Luer Lock Adapter · 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 00085412068664), received between Jun 3, 2025 and Jun 3, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Air/Gas in Device” (2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Air/Gas in Device2
- Backflow2
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.
MalfunctionJun 3, 2025Backflow; Air/Gas in Device; Backflow; Air/Gas in Device
IT WAS REPORTED THAT BACKFLOW AND AIR WERE OBSERVED DURING USE OF AT LEAST ONE (1) NON-DEHP SECONDARY MEDICATION SET. THE PROCESS STEP WAS NOT SPECIFIED. THE SECONDARY SET WAS CONNECTED TO A 500 ML BAG ETOPOSIDE PLUS A NON-DEHP EXTENSION SET THAT WAS "Y'D" (CONNECTED) TO A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET VIA A SIGMA SPECTRUM INFUSION PUMP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22137226 ↗MalfunctionJun 3, 2025Backflow; Air/Gas in Device; Backflow; Air/Gas in Device
IT WAS REPORTED THAT BACKFLOW AND AIR WERE OBSERVED DURING USE OF AT LEAST ONE (1) NON-DEHP SECONDARY MEDICATION SET. THE PROCESS STEP WAS NOT SPECIFIED. THE SECONDARY SET WAS CONNECTED TO A 500 ML BAG ETOPOSIDE PLUS A NON-DEHP EXTENSION SET THAT WAS "Y'D" (CONNECTED) TO A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET VIA A SIGMA SPECTRUM INFUSION PUMP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22136423 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.