Halyard 40784Recalls & reported problems
Avanos Medical, Inc. · HYHSURGPN,ON-Q-TBLOC,ECTUHY,-,4",5 · Class 2
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10680651407846), received between Feb 3, 2017 and Mar 6, 2020 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (4 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
Device problems
- Break4
- Material Fragmentation1
Patient problems
- No Known Impact Or Consequence To Patient4
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 6, 2020Material Fragmentation; Material Fragmentation
IT WAS REPORTED THE CATHETER WAS INSERTED IN THE PATIENT BUT SHREDDED. THE PHYSICIAN USED ANOTHER CATHETER TO COMPARE THE LENGTH TO SEE IF EVERYTHING WAS REMOVED, BUT THE TIP WAS MISSING ON THE REMOVED CATHETER. THE PATIENT WAS REPORTED TO BE "OK" AT THE TIME OF THE INCIDENT. THE PATIENT WAS UNDERGOING A PAIN PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9799266 ↗MalfunctionOct 12, 2018Break; Break
FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN . PROCEDURE: TAP BLOCK. CATHPLACE: TAP BLOCK. IT WAS REPORTED THE ANESTHESIOLOGIST WAS PERFORMING A TAP BLOCK AND WHEN HE TRIED TO REMOVE THE STYLET FROM THE T-BLOC CATHETER HE COULD NOT PULL BACK THE STYLET AND HAD TO PERFORM THE PROCEDURE AGAIN WITH A NEW TRAY. ADDITIONAL INFORMATION RECEIVED 13-SEP-2018 STATED THE CATHETER WAS SHEARED WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE NEEDLE. AS HE PULLED THE NEEDLE OUT AND MET RESISTANCE, THE CATHETER SHEARED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7959860 ↗MalfunctionApr 26, 2018Break; Break
IT WAS REPORTED THE CATHETER BROKE DURING USE. THE CATHETER BROKE IN HALF AFTER IT WAS PLACED BY ANESTHESIA HEALTHCARE PROFESSIONAL. THE HEALTHCARE PROFESSIONAL WAS ADMINISTERING A LOCAL ANESTHETIC. THE HEALTHCARE PROFESSIONALS WERE ABLE TO RETRIEVE BOTH PIECES OF THE CATHETER. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7466011 ↗MalfunctionFeb 3, 2017Break; Break
HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 2026095-2017-00011 FOR THE SECOND PATIENT. FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: UNKNOWN, CATHPLACE: PARAVERTEBRAL BLOCK. IT WAS REPORTED THAT A CATHETER BROKE OFF INSIDE A PATIENT. THERE WAS NO REPORTED PATIENT INJURY. NO FURTHER INFORMATION WAS RECEIVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6301785 ↗MalfunctionFeb 3, 2017Break; Break
HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2026095-2017-00010 FOR THE FIRST PATIENT. FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: UNKNOWN, CATHPLACE: PARAVERTEBRAL BLOCK. IT WAS REPORTED THAT A CATHETER BROKE OFF INSIDE A PATIENT. THERE WAS NO REPORTED PATIENT INJURY. NO FURTHER INFORMATION WAS RECEIVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6301783 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.