Closed Wound Suction 0071360Recalls & reported problems
C. R. Bard, Inc. · 100cc Silicone Closed Wound Suction Evacuator Kit, 100cc Silicone Evacuator with Anti-Reflux Valve, Hubless Silicone Flat Drain, 7mm Wide, 20cm Long, 3/4 Perforated Drain, X-Ray Opaque · Class 1
All models of Closed Wound Suction (24)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741049644), received between May 24, 2018 and Nov 6, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material2
- Break1
- Contamination /Decontamination Problem1
- Disconnection1
- No Device Output1
- Packaging Problem1
- Partial Blockage1
- Suction Problem1
Patient problems
- No Known Impact Or Consequence To Patient3
- No Consequences Or Impact To Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 6, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THERE WAS A SMALL PIECE OF PLASTIC ON TUBING IN STERILE PACKAGE OF THE SUCTION EVACUATOR.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 18074684 ↗MalfunctionNov 1, 2018Device Contamination with Chemical or Other Material; Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material; Packaging Problem
IT WAS REPORTED THAT THERE WERE SEVERAL BLACK SPECKS EMBEDDED INTO THE PACKAGING AND THE DEVICE.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 8028320 ↗MalfunctionMay 25, 2018Break; Suction Problem; Suction Problem
IT WAS REPORTED THAT THE WOUND DRAIN WAS NOT DRAINING PROPERLY. THE DRAIN TUBE WAS ALLEGEDLY FLUSHED WITH 10CC OF SALINE BUT THE COMPRESSED BULB DID NOT EXPAND. A FLUSH WAS USED WITH A STOP COCK TO FORCE FLUID INTO DRAIN, AT WHICH TIME IT POPPED THE ONE WAY VALVE FLAP OFF DRAIN, WHICH STARTED TO DRAIN 30-40 CC BILE/EFFULENT.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 7546349 ↗MalfunctionMay 24, 2018Partial Blockage; Disconnection; No Device Output; Disconnection
IT WAS REPORTED THAT THE WOUND DRAIN WAS NOT DRAINING PROPERLY. THE DRAIN TUBE WAS ALLEGEDLY FLUSHED WITH 10CC OF SALINE BUT THE COMPRESSED BULB DID NOT EXPAND. A FLUSH WAS USED WITH A STOP COCK TO FORCE FLUID INTO DRAIN, AT WHICH TIME IT POPPED THE ONE WAY VALVE FLAP OFF DRAIN, WHICH STARTED TO DRAIN 30-40 CC BILE/EFFULENT.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 7542379 ↗
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
- CARDINAL HEALTH SU130-403DCardinal Health 200, LLC · APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED1 recall0 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 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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