Closed Wound Suction 0071440Recalls & 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, X-Ray Opaque · Class 1
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741049675), received between Apr 26, 2017 and Apr 22, 2025 — classified as 3 injuries, 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Detachment Of Device Component2
- Defective Device1
- Detachment of Device or Device Component1
Patient problems
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 22, 2025Defective Device; Defective Device
IT WAS REPORTED THAT WOUND DRAINAGE HAD A MALFUNCTION 10MM JP DRAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21881857 ↗InjuryJul 16, 2019Break; Detachment of Device or Device Component
IT WAS REPORTED THE DRAIN BROKE APART WHEN THE PHYSICIAN ATTEMPTED REMOVAL, LEAVING A PIECE EMBEDDED IN THE PATIENT. THE DRAIN WAS PUT IN PLACE ON (B)(6) 2019 AND THE REMOVAL ATTEMPT ON (B)(6) 2019. THE RETAINED PORTION WAS REMOVED VIA SURGERY THE NEXT DAY ON (B)(6) 2019.
Patient problems: Foreign Body In Patient
MAUDE report 8794658 ↗InjuryMay 19, 2017Break; Detachment Of Device Component
IT WAS REPORTED THAT PART OF THE DRAIN RIPPED AND A PIECE OF THE DRAIN WAS LEFT INSIDE OF THE PATIENT. AN ADDITIONAL SURGICAL PROCEDURE HAD TO BE PERFORMED IN ORDER TO GET THE PIECE OF THE DRAIN OUT OF THE PATIENT.
Patient problems: No Code Available
MAUDE report 6578669 ↗InjuryApr 26, 2017Detachment Of Device Component
IT WAS REPORTED THAT THE PERFORATED POTION OF THE DRAIN REMAINED IN THE WOUND AFTER THE DRAIN WAS REMOVED. THE DRAIN WAS INSERTED (B)(6) 2017. IT WAS LATER REPORTED THAT THE PATIENT WAS SCHEDULED FOR A RADICAL LEFT GROIN DISSECTION REVISION FOR CLEAR MARGINS. WHILE RE-EXCISING THE PREVIOUS INCISION, THE SURGEON FOUND A PORTION OF RETAINED DRAIN IN THE WOUND. IT APPEARED THAT THE DRAIN HAD SEPARATED. THE WHITE PORTION OF THE DRAIN WAS FOUND IN THE WOUND AND REMOVED BY THE SURGEON.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 6521657 ↗
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.