ICU Medical 886-CH-14Recalls & reported problems
Icu Medical, Inc. · Vented Bag Spike, Clave™ · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00840619084592), received between Dec 6, 2018 and Feb 1, 2019 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak4
Patient problems
- No Consequences Or Impact To Patient3
- Chemical Exposure1
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 1, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE EVENT INVOLVED AN ALLEGATION OF A BROKEN SPIKE THAT RESULTED IN LEAKING OF CHEMOTHERAPY DRUG (EVOLTRA) AT THE SITE BETWEEN WHITE AND BLUE PART. THERE WAS PATIENT INVOLVEMENT, BUT NO BLOOD LOSS, NO UNPROTECTED CHEMO EXPOSURE AND NO ADVERSE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8297412 ↗MalfunctionJan 17, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT A VENTED BAG SPIKE WAS FOUND BROKEN AND WAS LEAKING CHEMOTHERAPY DRUG AT THE ASSEMBLY (BETWEEN BLUE SPIKE AND WHITE FEMALE LUER). THE DEVICE WAS REPLACED WITH NO FURTHER ISSUES. THERE WAS PATIENT INVOLVEMENT, BUT NO ADVERSE EVENT OR MEDICAL INTERVENTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8256625 ↗MalfunctionDec 6, 2018Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A VENTED BAG SPIKE LEAKED AN UNSPECIFIED CHEMOTHERAPEUTIC AGENT THROUGH THE AIR VENT DURING AN INFUSION. THE DEVICE WAS REPORTED TO HAVE BEEN REPLACED AND THERAPY WAS RESUMED WITHOUT INCIDENT. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THE EVENT. NO ADDITIONAL INFORMATION WAS RECEIVED.
Patient problems: Chemical Exposure; No Consequences Or Impact To Patient
MAUDE report 8139860 ↗MalfunctionDec 6, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE EVENT INVOLVED A VENTED BAG SPIKE, CLAVE THAT LEAKED AT THE CLAVE CONNECTION DURING SET-UP OF CHEMOTHERAPY BEFORE INFUSION TO THE PATIENT. THE DEVICE WAS REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED. THERE WAS NO PATIENT INVOLVEMENT, NO SERIOUS INJURY, NO MEDICAL INTERVENTION REQUIRED, NO BLOOD LOSS NOR CHEMO EXPOSURE.
Patient problems: No Patient Involvement
MAUDE report 8139096 ↗
Other Stopcock, i.V. Set devices
- Connecta, Luer-Lok 394910BD Switzerland Sàrl · Stopcock, i.V. Set3 recalls8 reports
- Outlook® 490361B. Braun Medical Inc. · Stopcock, i.V. Set3 recalls0 reports
- Blood Administration Set 490530B. Braun Medical Inc. · Stopcock, i.V. Set2 recalls11 reports
- Medex MX9341LIcu Medical, Inc. · Stopcock, i.V. Set63 reports
- ICU Medical AC135Icu Medical, Inc. · Stopcock, i.V. Set1 recall10 reports
- IV Administration Set 490067B. Braun Medical Inc. · Stopcock, i.V. Set1 recall9 reports
- ICU Medical MC330174Icu Medical, Inc. · Stopcock, i.V. Set1 recall4 reports
- ICU Medical Z2587Icu Medical, Inc. · Stopcock, i.V. Set1 recall3 reports
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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