Silicone Flat Drain 0070440Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00801741090769), received between Jul 25, 2017 and Jan 21, 2026 — classified as 17 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryJan 21, 2026Material Fragmentation

  IT WAS REPORTED THAT THE DRAIN HAD BEEN GIVEN TO THE STERILE FIELD, AND AS THE SURGEON ATTEMPTED TO PLACE THE DRAIN, THEY NOTED THAT PIECES OF THE DRAIN HAD COME OFF INTO THE WOUND. THE PIECES WERE REMOVED, AND THE DRAIN WAS REMOVED FROM THE STERILE FIELD.

  Patient problems: Foreign Body In Patient

  MAUDE report 24140297 ↗
• InjuryDec 12, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WHILE REMOVING THE WOUND DRAIN TUBE IT BROKE OFF IN THE PATIENT. THEY HAD TO TAKE THE PATIENT TO OPERATING ROOM AND REMOVE THE TUBE. UNKNOWN WHAT QUADRANT THE TUBE WAS LOCATED. PATIENT OUTCOME UNKNOWN IF THEY WERE ABLE TO RETRIEVE IT. IT WAS NOTED THAT THE GIVEN LOT NUMBER WAS NGKU2457.

  Patient problems: Foreign Body In Patient

  MAUDE report 23796661 ↗
• MalfunctionJun 24, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT WHEN THE NURSE PRACTITIONERS (NP'S) WERE PLACING DRAINS AND THEY WERE NOTICING WHAT LOOKED LIKE PLASTIC RESIDUAL FALLING OFF ALONG THE FLAT DRAIN. CUSTOMER RESPONDED VIA EMAIL ON 09JUL2025, IT WAS REPORTED THAT NO PHYSICAL SAMPLE IS AVAILABLE. THERE WERE TWO CASES WHERE THE NURSE PRACTITIONERS (NP'S) RECOGNIZED IT AND THREW THEM OFF THE FIELD PRIOR TO NOTIFYING THAT IT WAS AN ISSUE. THEY WERE NOT USED ON PATIENTS AND THERE WAS NEVER ANY PATIENT HARM. THERE HAVE BEEN NO FURTHER ISSUES SINCE. CUSTOMER BELIEVED THERE WERE A TOTAL OF 4 DRAINS THAT WERE AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320005 ↗
• InjuryMay 20, 2025Flaked; Flaked

  IT WAS REPORTED THAT FLAT WHITE PART OF WOUND DRAIN HAD FRAYING PIECE THAT THEY HAD TO PEEL OFF BEFORE THE CASE. THE MANAGING DIRECTOR CONCERN WAS THAT ONE OF THOSE FRAYING PIECES WOULD REMAIN IN THE PATIENT AND CAUSED AN INFECTION. THEY HAD NOTICED IT ON EVERY DRAIN SINCE THE CONVERSION BACK IN DECEMBER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 22052122 ↗
• MalfunctionMay 13, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE WOUND DRAIN PIECES FELL APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22008575 ↗
• InjuryFeb 1, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT IMPLANTATION OF HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE. PATIENT RETURNED TO THE CLOSURE OF MEDIAN STERNOTOMY WITH STERNAL PLATING AND BILATERAL PECTORALIS MAJOR MUSCLE FLAPS. BILATERAL SUB-PECTORAL BARD BLAKE DRAINS WERE PLACED. IT WAS NOTED THAT THE LEFT JP DRAIN WITH ISSUES REMOVING ULTIMATELY SPLITTING HIGH IN CHEST. PATIENT RETURNED FOR REMOVAL OF THE RETAINED JP DRAIN.

  Patient problems: Foreign Body In Patient

  MAUDE report 18621852 ↗
• MalfunctionNov 20, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE WHITE FLAKES WERE FOUND ON THE DRAIN AFTER REMOVING FROM THE PACKAGING AND PRIOR TO INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18171290 ↗
• InjuryAug 22, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THERE WAS A SPINE CASE ON 20MAR2023, THE INCIDENT WAS RELATED TO A RETAINED PORTION OF DRAIN AFTER REMOVAL POST OPERATION. THEY WERE WONDERING IF THERE HAD BEEN PRIOR INCIDENTS WITH THIS SPECIFIC DRAIN BEING RETAINED IN THE BODY. ALSO ASKED IF THERE HAD BEEN PRIOR INCIDENTS OF THIS DRAIN BREAKING OFF OR ANY ISSUES WITH INTEGRITY OF THE DRAIN. PER ADDITIONAL INFORMATION RECEIVED ON 10AUG2023, CUSTOMER PROVIDED WITH THE ATTACHED IMAGES FOR THE DRAIN BREAKAGE, ALSO ASKED FOR INFORMATION ABOUT REMOVING IT WHEN IT WAS STUCK. REPRESENTATIVE HAD SENT THE CUSTOMER A COPY OF THE IFU. PER FOLLOW UP VIA EMAIL ON 09AUG2023, AN INPATIENT NURSE REMOVED THE DRAIN, DID NOT FEEL RESISTANCE UPON PULLING THE DRAIN OUT. HOWEVER, IT WAS FOUND LATER THE PART OF THE DRAIN WAS RETAINED IN THE PATIENT. THE PATIENT HAD TO RETURN FOR A PROCEDURE TO REMOVE THE RETAINED DRAIN. THEY HAVE INCLUDED PICTURES OF THE RETAINED PIECE OF DRAIN.

  Patient problems: Foreign Body In Patient

  MAUDE report 17596794 ↗
• MalfunctionAug 8, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT HAD TWO CHANNEL DRAINS AND THAT IT WAS BROKEN AT THE BLUE CONNECTOR. PER FOLLOW UP VIA EMAIL RECEIVED ON 27JUL2023, THE PATIENT HAD A THIRD DRAIN FAIL, BUT SO FAR, NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17479405 ↗
• InjuryJul 28, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A 10MM FLAT DRAIN WAS REMOVED FROM A PATIENT, WHO WAS ONE WEEK POST OPERATION. PER THE RESIDENT WHO REMOVED THE DRAIN, THE DRAIN WAS REMOVED WITHOUT INCIDENT AND WITHOUT ANY UNUSUAL RESISTANCE. WHEN CUSTOMER WENT TO REMOVE THE DRAIN, IT WAS NOTED BY THE RESIDENT A PORTION OF THE DRAIN APPEARED TO BE MISSING POSSIBLY CUT/TORN. THE RESIDENT ALSO NOTED A CUT/TEAR PROXIMALLY NEAR THE MISSING PORTION OF DRAIN. A RETAINED PORTION OF THE DRAIN WAS CONFIRMED VIA CT (COMPUTERIZED TOMOGRAPHY) SCAN, AND IT HAD TO BE SURGICALLY REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17413735 ↗
• InjuryDec 22, 2021Disconnection; Disconnection

  IT WAS REPORTED THAT THE SILICONE WOUND DRAIN WAS INSERTED DURING A SURGICAL PROCEDURE. STATED THAT DURING POST OPERATION DRAIN RETRIEVAL BY THE PHYSICIAN ASSISTANT, IT WAS NOTED THAT THE CONNECTING TUBE SEPARATED FROM THE FLAT DRAIN. HENCE, THE PATIENT WAS FORCED TO UNDERGO A SECOND RETRIEVAL PROCEDURE UNDER GENERAL ANESTHESIA TO REMOVE THE DRAIN AND THE PATIENT DISCHARGE WAS DELAYED BY ANOTHER DAY.

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

  MAUDE report 13059747 ↗
• MalfunctionOct 21, 2021Material Protrusion/Extrusion; Component Misassembled; Material Protrusion/Extrusion; Component Misassembled

  IT WAS REPORTED THAT THERE WAS A LITTLE PIECE OF PLASTIC HANGING DOWN FROM THE DRAIN AND IT WAS NOT USED ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12674067 ↗
• MalfunctionSep 28, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE FLAT SILICONE WOUND DRAINAGE HAD A HAIR INSIDE THE STERILE PACKAGE. PER FOLLOW UP INFORMATION RECEIVED FROM THE CUSTOMER VIA EMAIL ON 08SEP2021, IT DID NOT DELAY THE OPERATING ROOM (OR) TIME AND ANOTHER DEVICE WAS OPENED TO CONTINUE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12541063 ↗
• InjuryMay 26, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT SMALL BROKEN PIECES WERE FOUND UPON REMOVAL OF SILICONE FLAT DRAIN ON (B)(6) 2021 WHICH WAS PLACED ON (B)(6) 2021. ON (B)(6) 2021 THEY NOTED WEAKNESS AND TEAR AT BASE OF SILICONE AREA WITHOUT HOLES. AND THE THIRD INCIDENT WAS ABOUT THE DRAIN TEARING UPON REMOVAL AT THE BASE.

  Patient problems: Foreign Body In Patient

  MAUDE report 11886788 ↗
• MalfunctionMay 24, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT SMALL BROKEN PIECES WERE FOUND UPON REMOVAL OF LUMBER DRAIN ON (B)(6) 2021 WHICH WAS PLACED ON (B)(6) 2021. ON (B)(6) 2021 THEY NOTED WEAKNESS AND TEAR AT BASE OF SILICONE AREA WITHOUT HOLES. AND THE THIRD INCIDENT WAS ABOUT THE DRAIN TEARING UPON REMOVAL AT THE BASE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11872187 ↗
• MalfunctionMay 24, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT SMALL BROKEN PIECES WERE FOUND UPON REMOVAL OF LUMBER DRAIN ON 19MAR2021 WHICH WAS PLACED ON (B)(6) 2021. ON (B)(6) 2021 THEY NOTED WEAKNESS AND TEAR AT BASE OF SILICONE AREA WITHOUT HOLES. AND THE THIRD INCIDENT WAS ABOUT THE DRAIN TEARING UPON REMOVAL AT THE BASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11872184 ↗
• MalfunctionMay 20, 2020Device Contaminated During Manufacture or Shipping; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT HAIR WAS FOUND IN THE PACKAGE BEFORE IT WAS OPENED. IT WAS NOTED THAT IT WAS NOT OPENED AND NOT USED.

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

  MAUDE report 10074231 ↗
• MalfunctionMay 19, 2020Device Contamination with Chemical or Other Material; Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS A STRAND OF HAIR IN THE DRAIN PACKAGE.

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

  MAUDE report 10070858 ↗
• InjuryMar 4, 2020Material Puncture/Hole; Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE DRAIN WAS LEAVING A BIGGER THAN USUAL BLAKE DRAIN HOLE IN THE PATIENT'S NECK.

  Patient problems: No Known Impact Or Consequence To Patient; Patient Problem/Medical Problem

  MAUDE report 9787336 ↗
• MalfunctionAug 2, 2019Break; Break

  IT WAS REPORTED THAT THE FLAT SILICONE DRAIN SNAPPED WHILE BEING REMOVED FROM THE PATIENT. NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8857238 ↗
• InjuryJul 17, 2019Break; Break

  IT WAS REPORTED THAT THE DRAIN IN THE RIGHT HIP BROKE OFF, LEAVING A PORTION OF THE DRAIN IN THE PATIENT. THE REMOVAL ATTEMPT WAS ON A TWO DAY POSTOPERATIVE RIGHT TOTAL HIP ARTHROPLASTY REVISION PATIENT. THE PATIENT REQUIRED SURGICAL INTERVENTION TO REMOVE THE RETAINED PORTION. THE DRAIN BROKE AT THE JUNCTION OF THE FLAT DRAIN TO THE TUBING.

  Patient problems: Foreign Body In Patient

  MAUDE report 8799730 ↗
• InjuryJun 3, 2019Break

  IT WAS REPORTED THAT THE WOUND DRAIN BROKE WHEN THE SURGEON WAS ATTEMPTING REMOVAL. PART OF THE DRAIN WAS RETAINED IN THE ABDOMEN. THE PATIENT'S INITIAL SURGERY WAS AN EXPLORATORY LAPAROTOMY FOR ABDOMINAL ABSCESS WITH SIGNS AND SYMPTOMS OF SEPSIS. THE PROCEDURE INCLUDED LYSIS OF ADHESIONS AND A LEFT SALPINGO-OOPHORECTOMY. THE DRAIN WAS NOT SUTURED IN PLACE AND REMOVAL ATTEMPT WAS THREE DAYS POST-OP. THE DRAIN BROKE AT THE TWO DRAIN EYES CLOSEST TWO THE HUB. A SECOND SURGERY WAS REQUIRED TO REMOVE THE RETAINED DRAIN PORTION AND IT IS REPORTED THE PATIENT HAD NO POST-OP COMPLICATIONS.

  Patient problems: Abscess; Adhesion(s); Foreign Body In Patient; Sepsis

  MAUDE report 8663788 ↗
• InjuryFeb 15, 2019Break

  IT WAS REPORTED THAT THE HUBLESS SILICONE FLAT DRAIN BROKE OFF IN THE PATIENT. THE PATIENT REQUIRED ADDITIONAL SURGERY IN ORDER FOR THE BROKEN PIECE TO BE REMOVED. PER ADDITIONAL INFORMATION RECEIVED ON THE MEDWATCH ON 05-FEB-2019: THE DRAIN WAS PLACED DURING A LUMBAR FUSION. TWO DAYS AFTER THE PROCEDURE, THE PHYSICIAN WAS REMOVING THE DRAIN AND THE DRAIN BROKE. THE SURGEON NOTED THAT THE DRAIN WAS NOT NEAR ANY SUTURE.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8342788 ↗
• InjuryNov 9, 2018Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PIECE OF THE DRAIN BROKE OFF WITHIN THE PATIENT AS THE DRAIN WAS BEING PULLED OUT. AN ADDITIONAL SURGERY WAS NEEDED TO REMOVE THE PIECE.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8056937 ↗
• MalfunctionJul 30, 2018Misassembled; Defective Device; Misassembled

  IT WAS REPORTED THAT THE SILICONE FLAT DRAIN WAS NOT FULLY PERFORATED. COMPLAINANT REPORTED THERE WAS ABOUT AN INCH OF THE DEVICE THAT WAS NOT PERFORATED.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 7731361 ↗