Ballard* Multi-Access Port Closed Suction System 20052Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00609038200521), received between Nov 6, 2023 and Jun 26, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2024Material Integrity Problem; Material Integrity Problem

  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 8030647-2024-00053 FOR THE FIRST REPORT. REFER TO 8030647-2024-00055 FOR THE THIRD REPORT. IT WAS REPORTED, "THE SUCTION SYSTEM BROKE AT THE ROTATION PART" WHEN THEY TRIED TO TURN THE PROBE. THE ENTIRE SYSTEM HAD TO BE CHANGED QUICKLY, WHICH EXTENDED THE TIME OF CARE. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 19616472 ↗
• MalfunctionJun 26, 2024Material Integrity Problem; Material Integrity Problem

  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 8030647-2024-00054 FOR THE SECOND REPORT. REFER TO 8030647-2024-00055 FOR THE THIRD REPORT. IT WAS REPORTED, THE SUCTION SYSTEM BROKE AT THE ROTATION PART WHEN THEY TRIED TO TURN THE PROBE; THE ENTIRE SYSTEM HAD TO BE CHANGED QUICKLY, WHICH EXTENDED THE TIME OF CARE. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 19616079 ↗
• MalfunctionJun 26, 2024Material Integrity Problem; Material Integrity Problem

  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 8030647-2024-00053 FOR THE FIRST REPORT. REFER TO 8030647-2024-00054 FOR THE SECOND REPORT. IT WAS REPORTED, THE SUCTION SYSTEM BROKE AT THE ROTATION PART WHEN THEY TRIED TO TURN THE PROBE. THE ENTIRE SYSTEM HAD TO BE CHANGED QUICKLY, WHICH EXTENDED THE TIME OF CARE. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 19616075 ↗
• MalfunctionJan 2, 2024Crack; Crack

  IT WAS REPORTED, WHEN CARING FOR AN INTUBATED PATIENT WITH A CLOSED SYSTEM, "AS PART OF ISOLATION FOR TUBERCULOSIS", THE PATIENT WAS PLACED IN THE PRONE POSITION, ON "THE SLICE ON THE STOMACH". THE CAREGIVERS HEARD A CRACKING NOISE FROM THE CLOSED SYSTEM; THE CLOSED SYSTEM WAS CHECKED IMMEDIATELY, AND NO LEAK WAS SEEN VISUALLY BUT AN AIR NOISE WAS HEARD; THE WHITE SAFETY CAP WAS FOUND "UNDONE" AND WAS REPLACED. THE CLOSED SYSTEM WAS CHANGED; THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED 22DEC2023 REPORTED, THE PATIENT EXPERIENCED TRANSIENT DESATURATION WHICH RESOLVED AFTER CHANGING THE SYSTEM; THERE WERE NO LONG -TERM CONSEQUENCES FOLLOWING THE INCIDENT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 18430544 ↗
• MalfunctionNov 6, 2023Material Integrity Problem; Material Integrity Problem

  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 (B)(4) FOR THE FIRST REPORT REFER TO (B)(4) FOR THE SECOND REPORT IT WAS REPORTED, THE SWIVEL CONNECTOR CAME APART (BROKE) ON THE CLOSED SUCTION CATHETER (CSC) DURING USE; THE DEVICE HAD REPORTEDLY BEEN IN PLACE FOR 2 DAYS. THERE WAS NO REPORTED INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18080589 ↗
• MalfunctionNov 6, 2023Material Integrity Problem; Material Integrity Problem

  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 8030647-2023-00143 FOR THE FIRST REPORT. REFER TO 8030647-2023-00145 FOR THE THIRD REPORT. IT WAS REPORTED, THE SWIVEL CONNECTOR CAME APART (BROKE) ON THE CLOSED SUCTION CATHETER (CSC) DURING USE; THE DEVICE HAD REPORTEDLY BEEN IN PLACE FOR 2 DAYS. THERE WAS NO REPORTED INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18080578 ↗
• MalfunctionNov 6, 2023Material Integrity Problem; Material Integrity Problem

  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 (B)(4) FOR THE SECOND REPORT REFER TO (B)(4) FOR THE THIRD REPORT IT WAS REPORTED, THE SWIVEL CONNECTOR CAME APART (BROKE) ON THE CLOSED SUCTION CATHETER (CSC) DURING USE; THE DEVICE HAD REPORTEDLY BEEN IN PLACE FOR 2 DAYS. THERE WAS NO REPORTED INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18080380 ↗