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Closed Wound Suction 0034630Recalls & reported problems

C. R. Bard, Inc. · ReliaVac 400 Closed Wound Suction Kit, Medium-Large 3/16"(15Fr., 2.3mm) O.D. PVC Drain, 12.5" Hole Pattern, X-Ray Opaque Stripe with Attached Trocar, 400cc Evacuator · Class 1 · Implant

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741049149), received between Sep 27, 2017 and Nov 1, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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

  • Burst Container or Vessel1
  • Device Markings/Labelling Problem1
  • Suction Failure1
  • Suction Problem1

Patient problems

  • No Consequences Or Impact To Patient2
  • No Known Impact Or Consequence To Patient2
  • No Information1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 1, 2018Device Markings/Labelling Problem

    IT WAS REPORTED THAT THERE WAS NO MARKER PRINTED ON THE DRAINE TUBE.

    Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

    MAUDE report 8028779 ↗
  • MalfunctionJul 25, 2018Suction Problem; Suction Failure; Suction Problem

    IT WAS REPORTED THAT THE EVACUATOR WAS UNABLE TO SUCTION FROM THE WOUND DRAIN.

    Patient problems: No Consequences Or Impact To Patient; No Information

    MAUDE report 7719866 ↗
  • MalfunctionSep 27, 2017Burst Container or Vessel

    IT WAS REPORTED THAT THE BALLOON BURST DURING PATIENT USE. THE USER SAID THAT THEY DID NOT APPLY EXCESSIVE PRESSURE TO THE BALLOON, AND NO INJURY WAS REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6898416 ↗

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.