Primary Sets B917801Recalls & reported problems
ICU Medical, Inc. · PRIMARY SET CLAVE Y-Site, 100 Inch, Non-DEHP · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887787009276), received between Sep 27, 2024 and Sep 27, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Air/Gas in Device” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- May 12, 2026Open, Classified
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.
Z-3160-2026 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Air/Gas in Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 27, 2024Air/Gas in Device; Air/Gas in Device
THE EVENT INVOLVED A PRIMARY SET, CLAVE Y-SITE, 100 INCH, NON-DEHP WHERE THE CUSTOMER REPORTED THAT THE INFUSION PUMP USED WITH THE SET CONTINUED TO INFUSE AFTER THE BAG OF MEDICATION RAN OUT, INFUSING APPROXIMATELY 5 ML OF AIR INTO THE PATIENT. THE RN ON DUTY WAS ABLE TO USE A SYRINGE TO PULL OUT THE 5 ML OF AIR. ADDITIONALLY, THE CUSTOMER STATED THAT THEY ARE NOT SURE ON WHAT WAS DEFECTIVE. THEY RAN THE PUMP AND THE TUBING SET THROUGH TESTING AND COULDN'T RECREATE THE ISSUE THAT HAPPENED. THE TESTING OF THE PUMP AND TUBING SET ALL PASSED INSPECTIONS. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20320304 ↗
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- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.