Silicone Round Drain 0070220Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741049446), received between May 16, 2019 and Dec 26, 2024 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 26, 2024Device Contamination with Body Fluid; Device Contamination with Body Fluid

  IT WAS REPORTED THAT CUSTOMER HAD HALF-OPENED SILICONE BARD WOUND DRAIN THAT WAS BROUGHT BY A TECHNICIAN. CUSTOMER WAS ABOUT TO USE BUT NOTICED IT ACTUALLY HAD A HAIR IN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21018395 ↗
• InjuryApr 10, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE DOCTOR GAVE ORDER TO REMOVE THE WOUND DRAIN. THE REGISTERED NURSE, AND NURSE MANAGER WENT ON TO REMOVE THE DRAIN. SUTURES WERE REMOVED AND AS THEY WENT TO GENTLY PULL, A LOT OF RESISTANCE WAS MET ONLY ¼ INCH APPROXIMATELY CAME OUT. DOCTOR WAS NOTIFIED, DRAIN WAS NOT REMOVED DUE TO RESISTANCE AND THE DOCTOR STATED THAT THEY WOULD COME TO THE FLOOR AND LOOK AT IT. DOCTOR CAME AND WAS TOLD OF THE JP SITUATION AND THAT NURSING STAFF DID NOT FEEL COMFORTABLE REMOVING. DOCTOR ATTEMPTED TO REMOVE THE DRAIN WHEN JP LINE WAS PULLED ON, IT SNAPPED IN HALF WITH A LOUD POP, BULB, AND PARTIAL PIECE OF JP TUBING IN HAND WHILE THE OTHER HALF WENT BACK INTO THE PATIENT. DOCTOR GAVE ORDER TO MAKE NOT BY MOUTH (NPO), PATIENT WOULD NEED SURGERY FOR REMOVAL DUE TO NOT BEING ABLE TO RETRIEVE AT BEDSIDE. PATIENT WAS AWARE OF THE PLAN AND WAS INSTRUCTED NOTHING TO EAT OR DRINK. CHLORHEXIDINE GLUCONATE (CHG) BATH WAS GIVEN, AND SURGERY PREPARATION PERFORMED. DRESSING APPLIED TO THE SITE AND SCANT BLEEDING WAS NOTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient

  MAUDE report 19080233 ↗
• MalfunctionNov 21, 2022Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE SILICONE ROUND DRAIN (MAT CODE 113357) USED FOR A BREAST MASTECTOMY WAS REMOVED BY DOCTOR AND STATED THAT DRAIN WAS TOO ROUGH AND MIGHT CAUSE TRAUMA TO THE SURGICAL SITE UPON REMOVAL. ANOTHER SILICONE DRAIN WAS OPENED, CARDINAL BRAND (MAT CODE 30793), WHICH WAS SMOOTHER AND DID NOT HAVE THE ROUGH EDGES THAT WOULD TRAUMATIZE THE SURGICAL SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15833486 ↗
• InjuryOct 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CUSTOMER HAD POST OPERATIVE COMPLICATION. THE REPORTER WAS UNABLE TO DESCRIBE. THE SURGEON REQUESTED REPORTED TO INITIATE RL6. MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15656666 ↗
• MalfunctionDec 4, 2019Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A HAIR WAS FOUND INSIDE OF THE WOUND DRAIN.

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

  MAUDE report 9410690 ↗
• InjuryMay 17, 2019Break; Product Quality Problem

  IT WAS REPORTED THAT THE PATIENT'S WOUND DRAIN BROKE DUE TO THE MATERIAL BEING TOO THIN. THE PATIENT WAS STATUS POST PILONIDAL CYST SURGERY. IT IS UNKNOWN IF THE PATIENT HAD TO RETURN TO THE OPERATING ROOM FOR REMOVAL OF THE RETAINED DRAINED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8621870 ↗
• InjuryMay 16, 2019Break; Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE WOUND DRAIN MATERIAL WAS TOO THIN RESULTING IN THE WOUND DRAIN BREAKING INSIDE OF THE PATIENT. THE PATIENT WAS POST BREAST RECONSTRUCTION WITH TISSUE EXPANDERS. IT WAS NOTED THAT THE PATIENT HAD TO RETURN TO THE OPERATING ROOM FOR THE REMOVAL OF THE RETAINED DRAINED.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 8615638 ↗