10 in. (25 cm) Q2 Checkmate extension set 9545Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00634624095458), received between Aug 5, 2016 and Nov 8, 2017 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2017Leak/Splash; Device Operates Differently Than Expected

  THE HOSPITAL REPORTED AN ISSUE ENCOUNTERED WITH THE INTRAVENOUS ADMINISTRATION EXTENSION SET DURING USE. THE REPORT STATED THAT WHEN THEY TIGHTEN THE SPIN CONNECTOR ON THE DEVICE IT KEEPS TURNING AND "STRIPS" CAUSING PRODUCT TO LEAK; IT HAS HAPPENED ON MULTIPLE OCCASIONS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7011798 ↗
• MalfunctionAug 10, 2016Detachment Of Device Component; Device Operates Differently Than Expected

  THE HOSPITAL REPORTED AN ISSUE ENCOUNTERED WITH THE INTRAVENOUS ADMINISTRATION EXTENSION SET DURING USE. THE REPORT STATED THAT SOME OF THE LUER LOCKS DO NOT APPEAR TO HAVE A FIXED STOPPING POINT- LIKE THEY HAVE BEEN STRIPPED OUT. THE REPORT STATED THAT AS A RESULT THE INFUSION SETS WOULD THEN COME OFF OF THE MANIFOLD DURING THE PROCEDURES, CAUSING A DELAY IN THE PROCEDURE WHILE THE ISSUE WAS REMEDIED. THE COMPLAINANT REPORTED THAT OUT OF (B)(4) EACHES IN A BOX OF THE PRODUCT THEY HAVE HAD ISSUES WITH AT LEAST (B)(4) OF THE DEVICES. A COMPLAINT SAMPLE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5865131 ↗
• MalfunctionAug 5, 2016Loose or Intermittent Connection; Material Separation; Material Integrity Problem

  THE HOSPITAL REPORTED AN ISSUE ENCOUNTERED WITH THE INTRAVENOUS ADMINISTRATION EXTENSION SET DURING USE. THE NURSE STATED THAT SHE WAS UNABLE TO TIGHTEN THE LUER CONNECTION WHERE THE TUBING AND THE MANIFOLD MEET. SHE SAID THAT IT CONTINUES TO SPIN AS IF STRIPPED, AND AS A RESULT IT CAN DISCONNECT DURING USE. FOLLOW UP WITH THE COMPLAINANT FOUND THAT THIS HAD BEEN A SPORADIC ISSUE FOR ABOUT A MONTH, UNTIL THEY BEGAN HEARING FROM THE ANESTHESIA PROVIDERS AND THE RECOVERY ROOM RNS THAT THE IV'S WERE "PULLING APART", ESPECIALLY AFTER TRANSFER/MOVEMENT OF PATIENTS. THE ADDITIONAL INFORMATION REPORTED THAT ON A COUPLE OCCASIONS, IV'S WERE ASSEMBLED IN ANTICIPATION OF BEING USED, AND PLACED ON AN IV POLE TO AWAIT THE PATIENT'S ARRIVAL. IT WAS DISCOVERED THAT THE IV HAD DISCONNECTED (AT THE MANIFOLD SITE DESCRIBED ABOVE) AND THE TUBING WAS ON THE FLOOR. NO ADDITIONAL SPECIFIC INFORMATION OTHER THAN THAT PROVIDED IS AVAILABLE. A DEVICE SAMPLE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5852140 ↗