Ballard* Multi-Access Port Closed Suction System 20070Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00609038200705), received between Nov 20, 2020 and Nov 26, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2020Break; Break

  IT WAS REPORTED THAT "THE INCIDENT WAS CAUSED BY THE BLOCKING OF THE GREEN PUSH BUTTON WHICH IS USED TO ALLOW THE ROTATION OF THE DIAL. AS A RESULT OF THIS BLOCKAGE, THE BUTTON BROKE. THEREFORE, THE CLOSED SYSTEM HAD TO BE CHANGED IN ITS ENTIRETY. THIS INCIDENT TOOK PLACE IN A PATIENT IN PRESSURE SUPPORT." NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED 06-NOV2020 INDICATED THAT APART FROM CHANGING THE CLOSED SYSTEM, NO MEDICAL INTERVENTION WAS NECESSARY. THE INCIDENT WAS FURTHER DESCRIBED AS "THE KIND OF GREEN PUSH BUTTON THAT YOU HAVE TO PRESS TO ALLOW THE WHEEL TO ROTATE WAS BLOCKED...TRIED TO TURN IT IN ALL SENSE AND TAKE MY TIME, IT ENDED UP BREAKING AND I TURNED THE RING INTO THE VOID. WE HAD TO CHANGE THE ENTIRE CLOSED SYSTEM IN A PATIENT USING INSPIRATORY SUPPORT (THEREFORE NEED TO CLAMP THE INTUBATION PROBE WITH KOCHER FORCEPS IN A PATIENT WITH ALMOST NO RESERVE) [PHYSICIAN] WAS PRESENT AND ACCOMPANIED US DURING THE CHANGE OF MATERIAL WHICH WENT WELL."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10909305 ↗
• MalfunctionNov 20, 2020Break; Crack; Break; Crack

  IT WAS REPORTED THAT A CRACK CAUSED THE SYSTEM TO SNAP IN HALF, CAUSING IMMEDIATE LOSS OF VOLUME TO THE PATIENT. THE SYSTEM WAS REPLACED. ADDITIONAL INFORMATION RECEIVED 05-NOV-2020 INDICATED, "ENDOTRACHEAL ASPIRATION REQUIRED IN COVID19 PATIENT, BY TURNING THE DOUBLE PIVOT ELBOW TO ALIGN THE SUCTION TUBE WITH THE INTUBATION TUBE, THE ELBOW BROKE IN HALF." APART FROM CHANGING THE CLOSED SYSTEM, NO MEDICAL INTERVENTION WAS NECESSARY.

  Patient problems: No Code Available

  MAUDE report 10880297 ↗