Ballard* Multi-Access Port Closed Suction System 20072Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00609038200729), received between Mar 2, 2022 and Sep 11, 2024 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2024Leak/Splash; Leak/Splash

  AVANOS MEDICAL INC. 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 8030647-2024-00071 FOR THE SECOND REPORT, REFER TO 8030647-2024-00072 FOR THE THIRD REPORT. IT WAS REPORTED, WHEN THE SYSTEM WAS SETUP THE RINSING CHAMBER (POCKET BETWEEN THE CATHETER AND THE EXTERNAL ENVIRONMENT), SWELLED WITH WATER AND A LITTLE LATER LEAKED AND SPLASHED ON THE PATIENT. AFTER CHANGING, THE PROBLEM REMAINED; THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 16AUG2024 REPORTED, THE ISSUE OCCURRED WHEN THE VACUUM KIT WAS INSTALLED; THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20192533 ↗
• MalfunctionSep 11, 2024Leak/Splash; Leak/Splash

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 8030647-2024-00070 FOR THE FIRST REPORT REFER TO 8030647-2024-00071 FOR THE SECOND REPORT. IT WAS REPORTED, WHEN THE SYSTEM WAS SETUP THE RINSING CHAMBER (POCKET BETWEEN THE CATHETER AND THE EXTERNAL ENVIRONMENT), SWELLED WITH WATER AND A LITTLE LATER LEAKED AND SPLASHED ON THE PATIENT. AFTER CHANGING, THE PROBLEM REMAINED; THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 16AUG2024 REPORTED, THE ISSUE OCCURRED WHEN THE VACUUM KIT WAS INSTALLED; THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20192184 ↗
• MalfunctionSep 11, 2024Leak/Splash; Leak/Splash

  AVANOS MEDICAL INC. 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 8030647-2024-00070 FOR THE FIRST REPORT REFER TO 8030647-2024-00072 FOR THE THIRD REPORT. IT WAS REPORTED, WHEN THE SYSTEM WAS SETUP THE RINSING CHAMBER (POCKET BETWEEN THE CATHETER AND THE EXTERNAL ENVIRONMENT), SWELLED WITH WATER AND A LITTLE LATER LEAKED AND SPLASHED ON THE PATIENT. AFTER CHANGING, THE PROBLEM REMAINED; THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 16AUG2024 REPORTED, THE ISSUE OCCURRED WHEN THE VACUUM KIT WAS INSTALLED; THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20191197 ↗
• MalfunctionMar 2, 2022Physical Resistance/Sticking; Suction Failure; Physical Resistance/Sticking; Suction Failure

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED AT LEAST THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 8030647-2022-00071 FOR THE FIRST REPORT. REFER TO 8030647-2022-00072 FOR THE SECOND REPORT. IT WAS REPORTED THAT THE SUCTION CATHETER BECAME BLOCKED, WHICH PREVENTED CHANGING THE MODE OF THE MULTIFUNCTION CONNECTOR AND SWITCHING FROM BREATHING TO SUCTION. NO FURTHER INFORMATION WAS PROVIDED FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 13651776 ↗
• MalfunctionMar 2, 2022Physical Resistance/Sticking; Suction Failure; Physical Resistance/Sticking; Suction Failure

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED AT LEAST THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 8030647-2022-00071 FOR THE FIRST REPORT. REFER TO 8030647-2022-00073 FOR THE THIRD REPORT. IT WAS REPORTED THAT THE SUCTION CATHETER BECAME BLOCKED, WHICH PREVENTED CHANGING THE MODE OF THE MULTIFUNCTION CONNECTOR AND SWITCHING FROM BREATHING TO SUCTION. NO FURTHER INFORMATION WAS PROVIDED FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 13651772 ↗
• InjuryMar 2, 2022Physical Resistance/Sticking; Suction Failure; Physical Resistance/Sticking; Suction Failure

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED AT LEAST THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 8030647-2022-00072 FOR THE SECOND REPORT; REFER TO 8030647-2022-00073 FOR THE THIRD REPORT . IT WAS REPORTED THAT THERE WAS BREATHING DISTRESS OF THE INTUBATED PATIENT. IT WAS DETERMINED THAT THE CLOSED SYSTEM CATHETER (CSC) WAS BLOCKED AND COULD NOT SUCTION, DUE TO THE SUCTION PROBE BECOMING "STUCK" INSIDE THE MULTI-ACCESS PORT MANIFOLD. THE PATIENT IS COVID-POSITIVE AND THE CARER HAD TO DISCONNECT THE SYSTEM AND USED A "CONVENTIONAL PROBE" TO PERFORM SUCTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 13651768 ↗