44 in (112 cm) Q2 CheckMate Extension Set with inline checkvalve and Q2 Y-site 9541Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00634624095410), received between Jun 29, 2016 and Mar 1, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Slipped” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 1, 2017Leak/Splash; Device Slipped

  THE NURSE REPORTED AN ISSUE OCCURRED WITH THE IV ADMINISTRATION EXTENSION SET DURING USE. SHE STATED THE SET LEAKED DURING USE. FOLLOW-UP WITH THE COMPLAINANT FOUND THAT THE TUBING WAS LOOSE AND THE CONNECTOR KEPT ROTATING; IT WAS NOT TIGHTENING. THE REPORT STATED THE PATIENT WAS HIV POSITIVE AND THE LEAK RESULTED IN A LARGE AMOUNT OF BLOOD ON THE FLOOR. THE LOT NUMBER WAS NOT PROVIDED. THE DEVICE WAS DISCARDED BY THE HOSPITAL AND WILL NOT RETURN FOR EVALUATION. ADDITIONAL FOLLOW-UP ATTEMPTS HAVE NOT BEEN SUCCESSFUL.

  Patient problems: Blood Loss

  MAUDE report 6368206 ↗
• InjuryJun 29, 2016Device Slipped

  THE HOSPITAL REPORTED AN ISSUE ENCOUNTERED WITH THE FLUID DELIVERY DEVICE DURING USE. THE NURSE REPORTED THAT AT THE END OF THE TUBING WHERE THE 3 CHECK VALVES COME TOGETHER WOULD NOT TIGHTEN AND BLOOD LEAKED AS A RESULT. SHE MENTIONED THIS HAS HAPPENED THE LAST FOUR TIMES THEY HAVE USED THIS PRODUCT (NO DETAILS PROVIDED). THE REPORT STATED THAT THE CLINICAL STAFF DID NOT IMMEDIATELY NOTICE THE BLOOD LEAK AS THE PROCEDURE WAS A CORONARY ARTERY BYPASS GRAFT AND THE BLOOD LEAK OCCURRED UNDER THE DRAPE. FOLLOW UP WITH THE HOSPITAL FOUND THAT "NACI" WAS BEING ADMINISTERED THROUGH THE DEVICE AT THE TIME OF THE ALLEGED EVENT. THE DEVICE WAS DISCARDED BY THE HOSPITAL AND NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; HOWEVER, THEY CHOSE TO RETURN AN UNUSED DEVICE FROM THE SAME LOT TO HELP WITH THE COMPLAINT INVESTIGATION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 5758629 ↗