Halyard 40792Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10680651407921), received between Mar 24, 2017 and Aug 30, 2018 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. How this data works · Data updated Oct 13, 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.

• MalfunctionAug 30, 2018Break; Break

  IT WAS REPORTED THE CATHETER COIL WAS EXPOSED. ADDITIONAL INFORMATION RECEIVED 06-AUG-2018 STATED: THE ANESTHESIOLOGIST PERFORMED THE BLOCK AND NOTED THE CATHETER WAS SHEARED. A FASCIA ILIACA BLOCK WAS PERFORMED. THE CATHETER WAS TUNNELED THROUGH THE FASCIA BUT THE CATHETER WAS INSERTED BACKWARDS UP THE NEEDLE WHICH THE DOCTOR BELIEVES WAS SHEARED WHILE DOING SO. BECAUSE OF THIS, THERE IS A POSSIBILITY THAT THE CATHETER WAS ALREADY SHEARED WHILE IN THE PATIENT. THEY NOTICED THAT THE CATHETER WAS SHEARED WHEN THE CATHETER WAS REMOVED. THE ANESTHESIOLOGIST BELIEVES THERE " POSSIBLY" COULD BE A SMALL PIECE OF THE CATHETER IN THE PATIENT BUT WAS UNSURE. AT THAT TIME, THE CLINICIANS WERE NOT GOING TO PROCEED WITH ANY MEDICAL INTERVENTIONS TO CONFIRM IF THERE WERE ANY PIECES LEFT IN THE PATIENT AND OR REMOVE ANY PIECES THAT MAY HAVE BEEN LEFT. THE PATIENT WAS IN STABLE CONDITION AND THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION TO BE PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7836212 ↗
• MalfunctionJan 22, 2018Break; Break

  FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: TOTAL KNEE ARTHROPLASTY. CATHPLACE: ADDUCTOR CANAL. IT WAS ORIGINALLY REPORTED ON (B)(6) 2017 THAT A CATHETER SHEARED AS IT WAS BEING THREADED THROUGH THE NEEDLE. SINCE THE CATHETER SHEARED, THE COIL BECAME EXPOSED OUT OF THE CATHETER. WHILE THE DOCTOR WAS THREADING THE CATHETER AND PULLING OUT THE STYLET, IT WAS NOTICED THAT THE CATHETER HAD SHEARED AND EXPOSED THE COIL. IT WAS ASSUMED THAT THE CATHETER FRAYED WHEN THE HUB OF THE NEEDLE GOT STUCK AND THE DOCTOR FELT RESISTANCE. THERE WERE NO REMNANTS OF CATHETER THAT REMAINED IN THE PATIENT. NOR DID THE CATHETER BREAK INTO PIECES OR SEGMENTS. IT JUST SHEARED. THERE WAS NO REPORTED PATIENT INJURY. ACCORDING TO HALYARD HEALTH INTERNAL REPORTABILITY GUIDELINES, THIS WAS NOT CONSIDERED A REPORTABLE EVENT AT THE TIME. HOWEVER, DURING HALYARD HEALTH PRELIMINARY SAMPLE EVALUATION ON (B)(6) 2018, IT WAS CONFIRMED THAT THE CATHETER WAS ACTUALLY A BREAK, WHICH IS REPORTABLE PER HALYARD HEALTH INTERNAL REPORTABILITY GUIDELINES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7209365 ↗
• InjuryDec 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED 04-DEC-2017 STATED THE ANESTHESIOLOGIST CONFIRMED THAT THE PATIENT'S CONDITION WAS RESOLVING AS SHE WAS DISCHARGED ON (B)(6) 2017.THE ANESTHESIOLOGIST ALSO THINKS THAT THE CONDITION WAS NOT A TRUE INFECTION BUT A REACTION. NO MEDICAL DIAGNOSIS WAS OBTAINED.

  Patient problems: Unspecified Infection

  MAUDE report 7098593 ↗
• MalfunctionMar 24, 2017Break; Leak/Splash; Break; Leak/Splash

  FILL VOLUME: UNKNOWN, FLOW RATE: 4 ML/HR TO 6 ML/HR, PROCEDURE: ROTATOR CUFF REPAIR, CATHPLACE: NECK. A REPORT WAS RECEIVED STATING THE PHYSICIAN REPORTED A CATHETER BREAKAGE. ADDITIONAL INFORMATION RECEIVED 8-MAR-2017 STATED THE PROCEDURE WAS DONE ON THURSDAY AND THE PATIENT CAME BACK TO THE SURGERY CENTER ON FRIDAY TO HAVE THE LOCK REPLACED. THE PATIENT DID WELL AND THERE WAS NO INJURY TO THE PATIENT. THE CLINICIANS PERFORMED ANOTHER INTERSCALENE BLOCK ON FRIDAY. FURTHERMORE, THE PATIENT HAD A SINGLE SHOT NERVE BLOCK BEFORE SURGERY. THE PATIENT WENT HOME WITH AN ONQ PUMP THE SAME DAY AND STARTED TURNING ON THE PUMP TO 4 OR 6 ML/HR AROUND 10 PM AT NIGHT AS INSTRUCTED BY THE DOCTOR. THE PATIENT THEN REALIZED THE CATHETER WAS LEAKING FROM THE CRACK SO THE PATIENT CALLED THE MANUFACTURER HOTLINE THE SAME DAY. ON (B)(6) 2017, THE PATIENT WENT TO THE DOCTORS OFFICE TO GET THE CATHETER REMOVED AND REPLACED. THE PATIENT "WAS DOING OKAY" AT THAT TIME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6432928 ↗