Halyard 45255Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20680651452553), received between Oct 11, 2017 and Oct 12, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 12, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 8030647-2017-00102 FOR THE SECOND PATIENT. IT WAS REPORTED THAT AN "ASSISTANT NURSE MANAGER CONTACTED THE VALUE ANALYSIS MANAGER TO REPORT THE SPONGES WERE FALLING OFF OF THE ORAL CARE SWABS." ADDITIONAL INFORMATION WAS RECEIVED ON 17-SEP-2017 THAT STATED, "TWO DIFFERENT PATIENTS. BOTH WERE VENTED AND THE SWAB FELL OFF IN PATIENT¿S MOUTH. (PATIENT DID NOT BITE DOWN ON SWAB) THE SWAB WAS RETRIEVED AND DISCARDED. BOTH PATIENTS WERE IN THE PEDIATRIC INTENSIVE CARE UNIT AND NO PATIENT HARM WAS DONE. THIS WAS ON THE SUCTION SWAB PIECE OF THE MINI KIT." NO ADDITIONAL INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6943487 ↗
• MalfunctionOct 11, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 8030647-2017-00101 FOR THE FIRST PATIENT. IT WAS REPORTED THAT AN "ASSISTANT NURSE MANAGER CONTACTED THE VALUE ANALYSIS MANAGER TO REPORT THE SPONGES WERE FALLING OFF OF THE ORAL CARE SWABS." ADDITIONAL INFORMATION WAS RECEIVED ON 17-SEPT-2017 THAT STATED, "TWO DIFFERENT PATIENTS. BOTH WERE VENTED AND THE SWAB FELL OFF IN PATIENT¿S MOUTH. (PATIENT DID NOT BITE DOWN ON SWAB) THE SWAB WAS RETRIEVED AND DISCARDED. BOTH PATIENTS WERE IN THE PEDIATRIC INTENSIVE CARE UNIT AND NO PATIENT HARM WAS DONE. THIS WAS ON THE SUCTION SWAB PIECE OF THE MINI KIT." NO ADDITIONAL INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6940375 ↗