8.5 in (22 cm) 3 Double T-site IV Extension Set 95711Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00634624957114), received between Oct 18, 2016 and Oct 18, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2016Device Operates Differently Than Expected

  THE DISTRIBUTOR REPORTED AN ISSUE ENCOUNTERED BY ONE OF THEIR CUSTOMERS WHEN USING THE IV ADMINISTRATION EXTENSION SET. THE REPORT STATED THAT A 20CC LUER LOCK SYRINGE FULL OF BLOOD WAS ATTACHED TO ONE OF THE DEVICE PORTS, AND UPON INJECTION INTO THE PORT BLOOD SQUIRTED OUT OF ANOTHER PORT. THE REPORT STATED THE DEVICE WAS DISCARDED AND ANOTHER MANIFOLD WAS USED. THE PATIENT WAS 5 MONTHS OLD AND THE IV LINE WAS ATTACHED TO AN INTERNAL JUGULAR CENTRAL LINE. THE COMPLAINANT STATED THERE WAS NO HARM CAUSED TO THE PATIENT BUT THAT THE ISSUE HAD OCCURREC IN THREE DIFFERENT PROCEDURES. THE COMPLAINANT CHOSE TO RETURN SEVEN OF THE UNUSED DEVICE TO THE DISTRIBUTOR FOR ANALYSIS BY THE MANUFACTURER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6037669 ↗