CLEARLINK 2C8921Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00085412071718), received between Dec 13, 2019 and Sep 10, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Disconnection” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2020Material Deformation; No Flow; Material Deformation; No Flow

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM 3-PORT MANIFOLD SETS WOULD NOT FLOW. THE EVENT WAS FURTHER DESCRIBED AS TUBING WOULD KINK EASILY AND WOULD HAVE TO BE TAPED IN SEVERAL PLACES TO KEEP IT FROM KINKING; THE PRIMARY AREA OF KINKED TUBING WAS ON EACH END OF THE MANIFOLD. THE KINKED TUBING ALSO PREVENTED NEEDED MEDICATIONS OF SALINE FLUSH FROM FULLY BEING ADMINISTERED. THIS WAS IDENTIFIED DURING PATIENT USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10515040 ↗
• MalfunctionSep 9, 2020Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM 3-PORT MANIFOLD SETS LEAKED AND FELL APART. THIS WAS FURTHER DESCRIBED AS ¿THE FLUIDS WERE LEAKING OUT OF THE EXTENSION TUBING ONTO THE FLOOR, AND ONTO THE PATIENT¿S GURNEY AND OR TABLE¿. IT WAS STATED THAT ¿THE LEAKS WERE COMING FROM WHERE THE ANESTHESIA EXTENSION TUBING CONNECTS AND MANY TIMES THE TUBING JUST FELL APART¿. THIS WAS IDENTIFIED DURING PATIENT INFUSIONS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THESE EVENTS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10511273 ↗
• MalfunctionDec 13, 2019Disconnection; Disconnection

  IT WAS REPORTED AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM 3-PORT MANIFOLD GOT DISCONNECTED FROM THE DISTAL END OF AN UNKNOWN QUANTITY OF ONE-LINK NON-DEHP STANDARD BORE CATHETER EXTENSION SET. IT WAS FURTHER REPORTED, "AFTER CONNECTION WAS ESTABLISHED" THE USER WOULD HAVE TO MAKE ¿THREE QUARTERS OF TURN TO ESTABLISH CONNECTION¿. THIS ISSUE WAS IDENTIFIED DURING PATIENT USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9469112 ↗
• MalfunctionDec 13, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED LOOSE CONNECTIONS WERE OBSERVED IN AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM 3-PORT MANIFOLDS. THE EVENT WAS FURTHER DESCRIBED AS "LOOSE CONNECTIONS BETWEEN THE STOPCOCK MANIFOLD AND THE TUBING" WERE OBSERVED. THE EVENT WAS OCCURRED DURING PATIENT USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9467911 ↗