PLEUR-EVAC IPN028472Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 14026704631534), received between Jan 28, 2021 and Dec 1, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionDec 1, 2021Leak/Splash; Leak/Splash

  ALLEGED QUALITY ISSUE/INCIDENT: DRAINAGE LEAKAGE FOUND IN THE SEVERAL CONNECTIONS OF THE CHEST DRAIN TUBING. THE CONNECTION OF CHEST DRAIN TO PATIENT IS NOT WELL-SECURED AND GOT DISLODGED IF VIGOROUS MANIPULATION INVOLVED. WATER FUNNEL IS FOUND LEAKAGE IN THE CONNECTIONS TO WATER SEAL CHAMBER OF CHEST DRAIN. ADDITIONAL INFORMATION: THE PATIENT'S CONDITION IS STABLE. THE NURSE HAD TO DISPOSE OF THE DEFECTIVE CHEST DRAIN AND CHANGED A NEW CHEST DRAIN FOR THE PATIENT'S CONTINUED USE. NO SIMILAR ISSUE WAS FOUND IN THE NEW ONE.

  Patient problems: Insufficient Information

  MAUDE report 12911710 ↗
• MalfunctionJan 28, 2021Optical Distortion; Optical Distortion

  THERE IS A COMPLAINT THAT THE SURGEON NOT BEING ABLE TO SEE THE RADIOPAQUE MARKINGS ON THE DTRC-16S CATHETER. THEY HAVE A LOT FOR THE DTRC-20S CATHETERS THAT THEY HAVE ON THE SHELF, BUT NOT FOR THE DTRC-16S. THEY WOULD HAVE TO LOOK INTO ORDER HISTORY TO SEE WHEN THE LAST ORDER PLACED FOR DTRC-16S WAS TO TRY AND OBTAIN THE LOT FROM THAT ORDER. ADDITIONAL INFORMATION FROM MEDWATCH REPORT# (B)(4). THE PATIENT HAD 2 CHEST TUBES PLACED, AND NEITHER HAD A RADIOPAQUE MARKING TO VERIFY ITS LOCATION IN THE CHEST. PHYSICIAN ARRIVED ON A MONDAY MORNING AND MY PARTNER HAD ALREADY REVIEWED THE FILMS, NOTING THAT IT APPEARED BOTH CHEST TUBES APPEARED TO BE OUTSIDE THE CHEST OF THIS CRITICALLY ILL PATIENT (AS NO RADIOPAQUE MARKINGS WERE SEEN OVER THE LUNG FIELDS). PHYSICIAN REPORTED THEY HAVE NEVER HEARD OF A CHEST TUBE WITHOUT RADIOPAQUE MARKINGS, BUT THESE TELEFLEX TUBES DO NOT HAVE THEM. IT MADE PHYSICIANS WORRY THAT THIS CRITICALLY ILL PATIENT MIGHT BE AT HIGH RISK OF RAPID DEATH DUE TO TENSION PNEUMOTHORAX; WHEN PHYSICIAN HEARD THAT THE CHEST TUBES DID NOT APPEAR TO BE IN THE CHEST, THE FIRST THING PHYSICIAN DID WAS TO GO AND GET EQUIPMENT TO PUT IN NEW CHEST TUBES - THAT WOULD BE THE RATE L

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11243116 ↗