ASEPT 622289Recalls & reported problems
B Braun Interventional Systems, Inc · ASEPT PLEURAL DRAINAGE SYSTEM · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964317514), received between Nov 21, 2018 and Nov 21, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Suction Problem” (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
- Suction Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 21, 2018Suction Problem; Suction Problem
CUSTOMER AND PATIENT REPORTED BUBBLES PRESENT IN THE DRAIN LINE THROUGHOUT THE ENTIRE DRAINAGE PROCEDURE. CATHETER WAS PLACED DURING THE WEEK OF (B)(6) 2018. PHYSICIAN NOTICED A SLIT IN THE CATHETER CLOSE TO ENTRY SITE ON (B)(6) 2018. CATHETER WAS REMOVED. ACCOUNT WILL WAIT FOR PATIENT TO HEAL AND POTENTIALLY PLACE ANOTHER CATHETER. CUSTOMER WAS NOT SURE IF THE SLIT WAS CAUSED BY ANYTHING DONE BY THE PHYSICIAN OR STAFF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8095184 ↗
Other APPARATUS, SUCTION, PATIENT CARE devices
- PleurX 50-7050Carefusion 2200, Inc · APPARATUS, SUCTION, PATIENT CARE137 reports
- PleurX 50-7500BCarefusion 2200, Inc · Apparatus, Suction, Patient Care66 reports
- Aspira® 00884450394946Merit Medical Systems, Inc. · APPARATUS, SUCTION, PATIENT CARE1 recall2 reports
- Aspira® 00884450394915Merit Medical Systems, Inc. · APPARATUS, SUCTION, PATIENT CARE1 recall2 reports
- Aspira® 00884450394861Merit Medical Systems, Inc. · APPARATUS, SUCTION, PATIENT CARE1 recall1 report
- Aspira Dressing Kit 4991503Bard Access Systems, Inc. · APPARATUS, SUCTION, PATIENT CARE1 recall0 reports
- Aspira® 00884450398173Merit Medical Systems, Inc. · APPARATUS, SUCTION, PATIENT CARE1 recall0 reports
- Aspira® 00884450394939Merit Medical Systems, Inc. · APPARATUS, SUCTION, PATIENT CARE1 recall0 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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