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Closed Wound Suction 0072360Recalls & 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 with Trocar, X-Ray Opaque · Class 1

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741050008), received between Dec 19, 2022 and Dec 21, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (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.

Most reported problems

Device problems

  • Component Misassembled1
  • Device Contamination with Chemical or Other Material1
  • Material Fragmentation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 21, 2022Material Fragmentation; Device Contamination with Chemical or Other Material; Material Fragmentation; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT THERE WAS A PRESENCE OF A SILICONE STOPPER INSIDE THE TUBING OF SUCTION EVACUATOR WHICH WAS PROXIMAL TO THE TROCAR. THE INTERNAL WHITE PART WAS PERFORATED ONLY ON THE TWO-THIRD INSTEAD OF WHOLE. THEREFORE, IT WAS IMPOSSIBLE TO USE ON CRANIOTOMY FOR TOO LONG AS IT WAS NOT PERFORATED THE FULL LENGTH.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16022890 ↗
  • MalfunctionDec 19, 2022Component Misassembled; Component Misassembled

    IT WAS REPORTED THAT THERE WAS A PRESENCE OF A SILICONE STOPPER INSIDE THE TUBING OF SUCTION EVACUATOR WHICH WAS PROXIMAL TO THE TROCAR. THE INTERNAL WHITE PART WAS PERFORATED ONLY ON THE TWO-THIRD INSTEAD OF WHOLE. THEREFORE, IT WAS IMPOSSIBLE TO USE ON CRANIOTOMY FOR TOO LONG AS IT WAS NOT PERFORATED THE FULL LENGTH.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16003905 ↗

Other APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED devices

All APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.