Closed Wound Suction 0072440Recalls & reported problems
C. R. Bard, Inc. · 100cc Silicone Closed Wound Suction Evacuator Kit, 100cc Silicone Evacuator with Anti-Reflux Valve, Hubless Silicone Flat Drain 10mm Wide, 20cm Long, Fully Perforated Drain with Trocar, X-Ray Opaque · Class 1
- 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 00801741050039), received between Jul 8, 2024 and Jul 8, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect Measurement” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Incorrect Measurement1
- Off-Label Use1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 8, 2024Incorrect Measurement; Off-Label Use; Incorrect Measurement; Off-Label Use
IT WAS REPORTED THAT CUSTOMER LOOKED TO REVIEW PRODUCT PRACTICE IN REGARD TO THE 100ML SILICONE CLOSED WOUND EVACUATOR BEING CONNECTED TO WALL SUCTION. THERE WERE A FEW SENTENCES IN THE PRODUCT INSTRUCTION FOR USE THAT CUSTOMER WOULD LIKE SOME CLARITY ON. CUSTOMER STATED THE DIMENSIONS OF THE INLET PORT ON BULB EVACUATOR HAD BEEN CHANGED. THEY USED TO DIRECTLY CONNECT SUCTION TUBING TO THIS CONNECTION AND USE CONTINUOUS WALL SUCTION. NOW THAT THE PORT SIZE HAD BEEN REDUCED, THEY WERE NO LONGER ABLE TO GET A SNUG CONNECTION TO WALL SUCTION. REPRESENTATIVE ADVISED THIS NEED TO BE INVESTIGATED. ANY CHANGES TO THE DEVICE SHOULD BE TESTED SO AS NOT TO AFFECT FORM, FIT OR FUNCTION. ADVISED THIS WAS AN OFF-LABEL USE OF THE PRODUCT AND BD CANNOT PROMOTE THIS USE OR COMMENT ON THE SAFETY OR EFFECTIVENESS OF USING THIS DEVICE OFF LABEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19690744 ↗
Other APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED devices
- Closed Wound Suction 0043610C. R. Bard, Inc. · APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED303 reports
- Closed Wound Suction 0070740C. R. Bard, Inc. · APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED192 reports
- Evacuator 0070800C. R. Bard, Inc. · APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED124 reports
- Closed Wound Suction 0034610C. R. Bard, Inc. · APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED62 reports
- CARDINAL HEALTH SU130-402DCardinal Health 200, LLC · APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED1 recall1 report
- NA 1A8504Baxter International Inc. · APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED50 reports
- CARDINAL HEALTH SU130-475Cardinal Health 200, LLC · APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED1 recall0 reports
- DLP® 10061Medtronic, Inc. · APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.