Silicone Round Drain 0070320Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741049477), received between Jul 17, 2018 and Oct 17, 2025 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2025Complete Blockage; Use of Device Problem; Complete Blockage; Use of Device Problem

  IT WAS REPORTED THAT CUSTOMER INQUIRED ABOUT THE DESIGN OF TROCARED DRAINS. THEY NOTED THAT, UNLIKE PREVIOUS DRAINS THEY HAD USED, THE CURRENT ONES APPEARED TO BE OCCLUDED AT THE TROCAR END, WHICH MIGHT BE AFFECTING DRAINAGE. ONE OF THEIR SURGEONS REMOVED THE TROCAR AND OBSERVED THAT THE DRAIN WAS NOT FUNCTIONING PROPERLY. CUSTOMER WAS ASKING WHETHER THAT OCCLUSION WAS INTENTIONAL BY DESIGN OR IF IT COULD BE A DEFECT. IF IT WAS INTENTIONAL, THEY WOULD LIKED TO ENSURE PROPER EDUCATION AND COMMUNICATION WITH THE SURGICAL TEAM, AS THAT WAS A NEW FEATURE FOR THEM.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23329875 ↗
• MalfunctionSep 30, 2025Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT TROCAR WAS TOO DULL. PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 02DEC2025, IT WAS REPORTED THAT THE CUSTOMER USED MUCH SHARPER TROCAR FROM A DIFFERENT VENDOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23179862 ↗
• MalfunctionApr 23, 2025Fracture; Fracture

  IT WAS REPORTED THAT ABOUT A WEEK AFTER THE WOUND DRAIN WAS PLACED DURING SURGERY, A CRACK APPEARED IN THE DRAIN. THERE SEEMED TO BE A LEAK FROM THE AREA WHERE THE BLUE TAPE WAS ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21892849 ↗
• MalfunctionAug 11, 2021Unclear Information; Unclear Information

  IT WAS REPORTED THAT THERE WAS NO BLACK MARKER TO INDICATE LENGTH OF THE WOUND DRAIN. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 28JUL2021 THERE WAS NO PHOTO SAMPLE AND IT WAS REPORTED THAT THERE WAS NO SCALES ON THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12309623 ↗
• MalfunctionAug 21, 2020Therapeutic or Diagnostic Output Failure; Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE WOUND DRAINAGE DID NOT WORK.

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

  MAUDE report 10438764 ↗
• MalfunctionFeb 5, 2020Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT UPON INSERTION AND REMOVAL, THE DRAIN BROKE OFF.

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

  MAUDE report 9671963 ↗
• MalfunctionJan 22, 2020Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS HAIR INSIDE THE PACKAGE OF THE WOUND DRAIN.

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

  MAUDE report 9617671 ↗
• MalfunctionNov 7, 2019Device Contamination with Chemical or Other Material; Material Discolored; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS A FOREIGN BLACK SPOT INSIDE OF THE WOUND DRAIN. THE SPOT WAS NOTED PRIOR TO USE.

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

  MAUDE report 9290429 ↗
• MalfunctionAug 22, 2019Break; Break

  IT WAS REPORTED THAT THE RELIAVAC WAS DAMAGED. PER ADDITIONAL INFORMATION RECEIVED FROM THE IBC VIA EMAIL ON 05AUG19, IT WAS REPORTED THAT THE DRAIN TUBE WAS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8923512 ↗
• InjuryJul 10, 2019Break; Break

  IT WAS REPORTED THAT THE WOUND DRAIN BROKE HALF-WAY THROUGH THE REMOVAL PROCESS WITH PART OF IT STILL IN THE PATIENT AFTER APPROXIMATELY 2-MONTHS OF USE. PATIENT WAS TAKEN TO SURGERY TO HAVE THE REMAINDER OF THE DRAIN REMOVED. ALLEGEDLY, THE DOCTOR HAD TO "TEASE AWAY" TISSUE IN-GROWTH FROM MULTIPLE LOCATIONS WITH IN THE DRAIN.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8776770 ↗
• InjuryJul 10, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT AFTER APPROXIMATELY 1 MONTH OF USE, THE WOUND DRAIN WAS BEING REMOVED WHEN THE NURSE NOTICED "PUCKERING" OF THE SKIN WHILE PULLING ON THE DRAIN. A WHICH TIME THE DOCTOR DECIDED TO SURGICALLY REMOVE THE DRAIN. ALLEGEDLY, THE PATENT ALSO HAD TISSUE IN-GROWTH IN THE DRAIN AND REPORTEDLY, THE DOCTOR WAS ONLY ABLE TO REMOVE IT WITHOUT BREAKING IT BECAUSE SHE DECIDED TO REMOVE THE DRAIN SURGICALLY.

  Patient problems: Patient Problem/Medical Problem; Skin Irritation

  MAUDE report 8776765 ↗
• MalfunctionJul 17, 2018Misassembled; Appropriate Device Problem Term/Code Not Available; Misassembled

  IT WAS REPORTED THAT THERE WAS NO MARKER ON THE DRAIN. THE SAMPLE WAS INDWELLING ON THE PATIENT. NO PATIENT INJURY REPORTED.

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

  MAUDE report 7695811 ↗