Halyard 13904Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 20680651139041), received between Apr 11, 2017 and Dec 28, 2017 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (7 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 28, 2017Detachment Of Device Component; Detachment Of Device Component

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE SECOND OF FIVE REPORTS. REFER TO 8030647-2017-00191 FOR THE FIRST PATIENT. REFER TO 8030647-2017-00193 FOR THE THIRD PATIENT. REFER TO 8030647-2017-00194 FOR THE FOURTH PATIENT. REFER TO 8030647-2017-00195 FOR THE FIFTH PATIENT. IT WAS REPORTED THE SPONGE SWAB TIP DETACHED FROM THE SUCTION CATHETER DURING ORAL CARE IN PATIENT¿S MOUTH. THE EVENT OCCURRED WITHOUT TRAUMA TO SWAB TIP (IE. NO BITING FROM PATIENT). THE SWAB TIP HAD TO BE RETRIEVED FROM PATIENT¿S MOUTH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7151200 ↗
• MalfunctionDec 28, 2017Detachment Of Device Component; Detachment Of Device Component

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE FIFTH OF FIVE REPORTS. REFER TO 8030647-2017-00191 FOR THE FIRST PATIENT. REFER TO 8030647-2017-00192 FOR THE SECOND PATIENT. REFER TO 8030647-2017-00193 FOR THE THIRD PATIENT. REFER TO 8030647-2017-00194 FOR THE FOURTH PATIENT. IT WAS REPORTED THE SPONGE SWAB TIP DETACHED FROM THE SUCTION CATHETER DURING ORAL CARE IN PATIENT¿S MOUTH. THE EVENT OCCURRED WITHOUT TRAUMA TO SWAB TIP (IE. NO BITING FROM PATIENT). THE SWAB TIP HAD TO BE RETRIEVED FROM PATIENT¿S MOUTH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7150889 ↗
• MalfunctionDec 28, 2017Detachment Of Device Component; Detachment Of Device Component

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE FIRST OF FIVE REPORTS. REFER TO 8030647-2017-00192 FOR THE SECOND PATIENT. REFER TO 8030647-2017-00193 FOR THE THIRD PATIENT. REFER TO 8030647-2017-00194 FOR THE FOURTH PATIENT. REFER TO 8030647-2017-00195 FOR THE FIFTH PATIENT. IT WAS REPORTED THE SPONGE SWAB TIP DETACHED FROM THE SUCTION CATHETER DURING ORAL CARE IN PATIENT¿S MOUTH. THE EVENT OCCURRED WITHOUT TRAUMA TO SWAB TIP (IE. NO BITING FROM PATIENT). THE SWAB TIP HAD TO BE RETRIEVED FROM PATIENT¿S MOUTH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7150887 ↗
• MalfunctionDec 28, 2017Detachment Of Device Component; Detachment Of Device Component

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE THIRD OF FIVE REPORTS. REFER TO 8030647-2017-00191 FOR THE FIRST PATIENT. REFER TO 8030647-2017-00192 FOR THE SECOND PATIENT. REFER TO 8030647-2017-00194 FOR THE FOURTH PATIENT. REFER TO 8030647-2017-00195 FOR THE FIFTH PATIENT. IT WAS REPORTED THE SPONGE SWAB TIP DETACHED FROM THE SUCTION CATHETER DURING ORAL CARE IN PATIENT¿S MOUTH. THE EVENT OCCURRED WITHOUT TRAUMA TO SWAB TIP (IE. NO BITING FROM PATIENT). THE SWAB TIP HAD TO BE RETRIEVED FROM PATIENT¿S MOUTH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7150885 ↗
• MalfunctionDec 28, 2017Detachment Of Device Component; Detachment Of Device Component

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE FOURTH OF FIVE REPORTS. REFER TO 8030647-2017-00191 FOR THE FIRST PATIENT. REFER TO 8030647-2017-00192 FOR THE SECOND PATIENT. REFER TO 8030647-2017-00193 FOR THE THIRD PATIENT. REFER TO 8030647-2017-00195 FOR THE FIFTH PATIENT. IT WAS REPORTED THE SPONGE SWAB TIP DETACHED FROM THE SUCTION CATHETER DURING ORAL CARE IN PATIENT¿S MOUTH. THE EVENT OCCURRED WITHOUT TRAUMA TO SWAB TIP (IE. NO BITING FROM PATIENT). THE SWAB TIP HAD TO BE RETRIEVED FROM PATIENT¿S MOUTH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7150874 ↗
• MalfunctionNov 30, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THE INITIAL REPORT CONTAINED STATEMENTS: REFER TO 8030647-2017-00151 FOR THE SECOND PATIENT. REFER TO 8030647-2017-00152 FOR THE THIRD PATIENT. HOWEVER, THE CORRECTED STATEMENTS SHOULD READ: REFER TO 8030647-2017-00150 FOR THE FIRST PATIENT. REFER TO 8030647-2017-00151 FOR THE SECOND PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7072429 ↗
• MalfunctionNov 30, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 8030647-2017-00150 FOR THE FIRST PATIENT. REFER TO 8030647-2017-00152 FOR THE THIRD PATIENT. IT WAS REPORTED THAT THE SWAB TIP ON THE SUCTION HANDLE CAME OFF IN THE PATIENT'S MOUTH. THIS EVENT HAPPENED THREE TIMES IN TWO DAYS. THE SWAB TIP WAS ABLE TO BE RETRIEVED FROM THE PATIENT'S MOUTHS WITHOUT INJURY TO THE PATIENTS. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7072407 ↗
• MalfunctionNov 30, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 8030647-2017-00151 FOR THE SECOND PATIENT. REFER TO 8030647-2017-00152 FOR THE THIRD PATIENT. IT WAS REPORTED THAT THE SWAB TIP ON THE SUCTION HANDLE CAME OFF IN THE PATIENT'S MOUTH. THIS EVENT HAPPENED THREE TIMES IN TWO DAYS. THE SWAB TIP WAS ABLE TO BE RETRIEVED FROM THE PATIENT'S MOUTHS WITHOUT INJURY TO THE PATIENTS. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7072399 ↗
• MalfunctionNov 28, 2017Break; Break

  IT WAS REPORTED THAT A SWAB SPONGE ON THE END OF THE TOOTHETTES WERE COMING OFF THE SUCTION HANDLE IN THE PATIENT'S MOUTH. THE CLINICIAN SUCCESSFULLY RETRIEVED THE SWAB FROM THE PATIENT'S MOUTH. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7064622 ↗
• MalfunctionJun 21, 2017Detachment Of Device Component; Detachment Of Device Component

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3006646024-2017-00013 FOR THE SECOND REPORT. IT WAS REPORTED THAT, "BRUSHES ARE BREAKING OFF IN THE PATIENT'S MOUTH. THE SUCTION HANDLE COMES APART WHILE IN USE AND THE PATIENT'S LIPS ARE MORE DRY THAN BEFORE. THE SUCTION TIP PROVIDES THE STAFF WITH DIFFICULTY IN SUCTIONING OUT THE ENTIRE ORALPHYRNAGEL AREA." NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6659104 ↗
• MalfunctionJun 21, 2017Detachment Of Device Component; Detachment Of Device Component

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 3006646024-2017-00012 FOR THE FIRST REPORT. IT WAS REPORTED THAT, "BRUSHES ARE BREAKING OFF IN THE PATIENT'S MOUTH. THE SUCTION HANDLE COMES APART WHILE IN USE AND THE PATIENT'S LIPS ARE MORE DRY THAN BEFORE. THE SUCTION TIP PROVIDES THE STAFF WITH DIFFICULTY IN SUCTIONING OUT THE ENTIRE ORALPHARYNGEAL AREA." NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6659082 ↗
• MalfunctionApr 11, 2017Break; Break

  IT WAS REPORTED WHILE PERFORMING ORAL CARE ON A PATIENT WHO MOUTH WAS DRY AND STICKY THE SUCTION SWAB BROKE OFF ON THE CURVED AREA AND INTO THE PATIENT¿S MOUTH. THE SPEECH PATHOLOGIST WAS ABLE TO REMOVE THE SWAB FROM THE PATIENT¿S MOUTH. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2017 STATED THE SWAB BROKE WITH THE ENTIRE STEM FALLING INTO THE PATIENT¿S ORAL CAVITY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6482352 ↗