Bardex® Malecot Model Drain 086032Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741023927), received between Dec 4, 2017 and Jan 4, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 4, 2018Occlusion Within Device

  IT WAS REPORTED THAT A (B)(6) MALE WAS ADMITTED TO THE HOSPITAL WITH AN UPPER GASTROINTESTINAL BLEED AND ESOPHAGEAL VARCIES, WHICH REQUIRED BLOOD TRANSFUSIONS AND INTUBATION. A NASOGASTRIC TUBE WAS NOT ABLE TO BE PLACED IN THE PATIENT DUE TO EPISTAXIS. THE PATIENT REQUIRED A RECTAL TUBE FOR LACTULOSE ADMINISTRATION AS NEEDED TO TREAT HEPATIC ENCEPHALOPATHY. A BARDEX MALECOT MODEL DRAIN, PRODUCT CATALOG NUMBER 086032, WAS PLACED RECTALLY IN THE PATIENT ON (B)(6) 2017 AND WAS INDWELLING UNTIL IT WAS REMOVED ON (B)(6) 2017. THE REASON FOR REMOVAL IS UNKNOWN. A SECOND MALECOT DRAIN, WITH THE SAME PRODUCT CATALOG NUMBER, WAS PLACED ON (B)(6) 2017 AND REMOVED ON THE SAME DAY DUE TO AN OCCLUSION. ON (B)(6) 2017, THE PATIENT DEVELOPED A LOWER GASTROINTESTINAL BLEED AND A SIGMOIDOSCOPY WAS PERFORMED REVEALING AN ULCERATION IN AN UNKNOWN AREA, WHICH WAS THE SOURCE OF THE BLEEDING. A HEMOSTATIC CLIP WAS PLACED TO STOP THE BLEEDING. ON (B)(6) 2017 AN EXTERNAL FECAL SYSTEM WAS PUT IN PLACE ON THE PATIENT FOR FECAL MANAGEMENT. THE PATIENT EXPIRED LATER IN THE MONTH OF NOVEMBER, HOWEVER ,THE EXACT DATE IS UNKNOWN. THE CAUSE OF DEATH WAS LIVER FAILURE. THE PATIENT HAD A HISTORY OF RENAL FAILURE AN

  Patient problems: Death; Hemorrhage/Blood Loss/Bleeding; Liver Damage/Dysfunction; Renal Failure; Ulceration

  MAUDE report 7163961 ↗
• MalfunctionDec 4, 2017Insufficient Device Problem Information

  RECTAL TUBE INSERTED ON ADMISSION (NON-BALLOONED) AND REPLACED DURING ADMISSION. NEEDED AS WAS UNABLE TO HAVE NASOGASTRIC TUBE RELATED TO EPISTAXIS. RECTAL TUBE NEEDED FOR LACTULOSE ADMINISTRATION. PATIENT SUFFERED LOWER RECTAL BLEED FROM A RECTAL ULCER REQUIRING CLIPPING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7078471 ↗