Ballard* Multi-Access Port Closed Suction System 10139Recalls & reported problems
Avanos Medical, Inc. · BALLARD* Multi-Access Port Catheter, Double Swivel Y, WET PAK* · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00609038101392), received between Aug 6, 2020 and Aug 6, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Disconnection” (1 report).
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 16, 2026.
Most reported problems
Device problems
- Disconnection1
- Inadequate Instructions for Healthcare Professional1
Patient problems
- Cardiac Arrest1
- Hypoxia1
- Respiratory Distress1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 6, 2020Disconnection; Inadequate Instructions for Healthcare Professional; Disconnection; Inadequate Instructions for Healthcare Professional
IT WAS REPORTED THAT THE HOSPITAL HAS HAD A PROBLEM WITH DISCONNECTION OF THE CLOSED SUCTION CATHETER. THIS RESULTED IN CARDIORESPIRATORY ARREST ON HYPOXIA, DETERIORATION RESPIRATORY STATE, PROLONGATION OF HOSPITALIZATION IN INTENSIVE CARE. PER ADDITIONAL INFORMATION RECEIVED 17 JUL 2020, THE PATIENT EXPERIENCED HYPOXIA AND CARDIAC ARREST AND WAS TREATED WITH 2MG ADRENALIN, FIO2 AT 100%, CURARIZATION AND SEDATION. THE PATIENT REQUIRED TWO MORE WEEKS IN THE INTENSIVE CARE UNIT. PER ADDITIONAL INFORMATION RECEIVED 20 JUL 2020, THE HOSPITAL REPORTS THAT THE INSTRUCTIONS PROVIDED WITH THE DEVICE ARE DIFFICULT TO UNDERSTAND AND USER TRAINING WILL BE PERFORMED. PER ADDITIONAL INFORMATION RECEIVED 22 JUL 2020, THE DOCTOR REPORTS THAT HE FOUND THE ENDOTRACHEAL TUBE DISCONNECTED FROM THE MULTI-ACCESS PORT CLOSE SUCTION SYSTEM. AFTER THE INCIDENT, THE ACTIONS TAKEN BY THE HOSPITAL WERE REPORTED AS "FORMATIONS AND ICU NURSES FOR SUPERVISION." THE SUCTION CATHETER HAD BEEN ATTACHED TO A 4 MED SERRES BAG WITH TUBING.
Patient problems: Cardiac Arrest; Hypoxia; Respiratory Distress
MAUDE report 10374674 ↗
Other CATHETERS, SUCTION, TRACHEOBRONCHIAL devices
- Ballard* Closed Suction System 93826Avanos Medical, Inc. · CATHETERS, SUCTION, TRACHEOBRONCHIAL1 recall70 reports
- Ballard* Closed Suction System 92431Avanos Medical, Inc. · CATHETERS, SUCTION, TRACHEOBRONCHIAL78 reports
- Medline DYNCPDS14Medline Industries, Inc. · CATHETERS, SUCTION, TRACHEOBRONCHIAL1 recall16 reports
- Ballard* Turbo-Cleaning Closed Suction System 98965Avanos Medical, Inc. · CATHETERS, SUCTION, TRACHEOBRONCHIAL1 recall16 reports
- Ballard* Turbo-Cleaning Closed Suction System 98263Avanos Medical, Inc. · CATHETERS, SUCTION, TRACHEOBRONCHIAL1 recall11 reports
- Ballard* Closed Suction System for Adults 98310Avanos Medical, Inc. · CATHETERS, SUCTION, TRACHEOBRONCHIAL1 recall1 death9 reports
- Medline DYNCPTP14TMedline Industries, Inc. · CATHETERS, SUCTION, TRACHEOBRONCHIAL1 recall6 reports
- Medline DYNCPTP14Medline Industries, Inc. · CATHETERS, SUCTION, TRACHEOBRONCHIAL1 recall4 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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