M-Drain Centesis Catheter D40105007Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15711055001981), received between Jun 4, 2021 and Jul 9, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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

Recent adverse event reports

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

• MalfunctionJul 9, 2021Packaging Problem

  PATIENT WITH HISTORY OF HYPERTENSION, CORONARY ARTERY DISEASE POST CORONARY ARTERY BYPASS GRAFT SURGERY X 5, AND RECENT LEFT PLEURAL EFFUSION WAS ADMITTED FOR AN ULTRASOUND GUIDED LEFT THORACENTESIS. DURING THE PREPARATION, IT WAS OBSERVED THAT THE NEEDLE FOR THIS CATHETER WAS LONGER THAN IT WAS SUPPOSED TO BE. THE PRODUCT MANUFACTURER IS MERMAID MEDICAL AND IT WAS A 5FX7CM M-DRAIN CENTESIS CATHETER. THIS DEVICE WAS NEVER USED IN THE PATIENT. PLEASE NOTE THAT THIS IS THE 4TH NEEDLE (3RD REPORT) THAT THE NEEDLE SIZE WAS INCORRECTLY PACKAGED.

  Patient problems: Pleural Effusion

  MAUDE report 12142279 ↗
• MalfunctionJul 7, 2021Device Markings/Labelling Problem

  PATIENT WITH A HISTORY OF HYPERTENSION, RECENT SHORTNESS OF BREATH, AND RIGHT PLEURAL EFFUSION WAS ADMITTED FOR A RIGHT THORACENTESIS. WHEN THE MERMAID MEDICAL A/S M-DRAIN CENTESIS CATHETER WAS OPENED, IT WAS OBSERVED THAT THE CATHETER THAT WAS IDENTIFIED AS A 5F X 7CM CENTESIS CATHETER HAD A NEEDLE THAT WAS 12 CM LONG INSTEAD. THIS DEVICE WAS NOT USED ON THE PATIENT. PLEASE NOTE THIS IS THE 3RD REPORT FOR THE SAME PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12127301 ↗
• MalfunctionJun 4, 2021Product Quality Problem; Inadequacy of Device Shape and/or Size; Defective Device

  PATIENT WITH HISTORY OF DIABETES MELLITUS, HYPERTENSION, PROGRESSIVE DYSPNEA, AND PLEURAL EFFUSION WAS ADMITTED FOR AN ULTRASOUND-GUIDED THORACENTESIS. WHEN OPENING THE M-DRAIN 5F X 7 CM CENTESIS CATHETER, HEALTH CARE PROVIDER(S) NOTICED THERE WAS A 10 CM NEEDLE IN THE 7 CM SHEATH. ANOTHER DEVICE WAS OPENED WITH THE SAME ISSUE WHERE THE NEEDLE WAS TOO LONG. BOTH M-DRAIN CENTESIS CATHETER HAD THE SAME LOT NUMBER. THIS EQUIPMENT WAS NOT USED ON THE PATIENT AS THE TECHNOLOGIST AND PA NOTICED THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11938063 ↗