Silicone Flat Drain 0070430Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00801741090752), received between Aug 29, 2017 and Dec 12, 2025 — classified as 9 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (10 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT HAIR WAS IDENTIFIED BEFORE DRAIN WAS USED. CLEAN PRODUCT PULLED AND USED INSTEAD. THERE WAS A MINOR DELAY TO PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23794667 ↗
• MalfunctionSep 30, 2025Flaked; Flaked

  IT WAS REPORTED THAT CUSTOMER HAD A SERIOUS CONCERN WITH THE WOUND DRAIN, STATING THAT A COMPONENT OF THE PRODUCT COULD BE EASILY TORN OFF, A PIECE OF THE PRODUCT DID BREAK OFF BASED ON THE PHOTO SAMPLE AVAILABLE POTENTIALLY POSING A PATIENT SAFETY RISK. THIS ISSUE HAD PROMPTED TWO HOSPITALS TO CONSIDER PULLING THE PRODUCT FROM USE IMMEDIATELY. A PREVIOUS RESPONSE IN APRIL FROM A FORMER REPRESENTATIVE CLAIMING THERE WAS NOTHING WRONG WITH THE PRODUCT HAD NOT BEEN WELL RECEIVED BY THE SURGEON OR THE HOSPITAL¿S PATIENT SAFETY AND QUALITY DEPARTMENT. PER ADDITIONAL INFORMATION RECEIVED ON 19SEP2025 VIA EMAIL, MAIN COMPLAINT WAS THE SEAM OF PLASTIC AT THE PROXIMAL PORTION OF THE DRAIN HAD EXTRA MATERIAL THAT FLAKED OFF. RECREATED WITH REPRESENTATIVE PRESENT ON SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23178919 ↗
• MalfunctionSep 18, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT IN APRIL 2025, AN ORIGINAL ISSUE WAS ESCALATED TO (B)(6) SUPPLY CHAIN RE: BARD PRODUCT#: 0070430 - 7MM FLAT DRAIN. THIS DRAIN HAS A FRAGILE PART OF THE DRAIN THAT CAN BE EASILY PULLED OFF. THIS WAS DISCOVERED BY AN ENT SURGEON PRIOR TO IMPLANTATION. IN (B)(6), A BARD REP WAS ONSITE, REVIEWED THE PRODUCT AND THE OFFERED OTHER PRODUCTS. AT THAT TIME, NO ISSUE WAS IDENTIFIED WITH THE PRODUCT. ON 7/30/2025, THIS ISSUE WAS AGAIN ESCALATED. DUE TO THE PIECE EASILY BEING REMOVED, CONCERN EXISTS FOR A POTENTIAL RETAINED FOREIGN BODY WHEN THE DRAIN WAS PULLED POST OPERATIVELY. ON 07/30, (B)(6) ENGAGED WITH BARD TO OBTAIN A DIFFERENT LOT#. THAT WAS RECEIVED ON 08/01. ON 07/30, NOTIFICATION WAS SENT TO THE OPERATING ROOM STAFF RE: THIS CONCERN. ON 08/05/2025, BARD REP ONSITE TO REVIEW ISSUE AND IDENTIFIED THE SAME ISSUE EXISTED ON THE OTHER LOT# BROUGHT IN. PER THE REP, THAT WILL BE INTERNALLY ESCALATED WITHIN BARD INVESTIGATION AND REVIEW. THESE DRAINS WERE BEING PULLED AND RETURNED TO BARD FROM (B)(6) HEALTH SITES. REFERENCE REPORT: MW5174384.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084132 ↗
• MalfunctionAug 22, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT CUSTOMER CALLED TO REPORT THAT WHEN THEY OPEN THE HUBLESS SILICONE FLAT DRAINS REF 0070430, THEY ARE SEEING LITTLE SILICONE PARTICLES IN THE LINE. SAMPLES AVAILABLE FOR RETURN, NO PT HARM, LOT NUMBER AVAILABLE BUT NOT PROVIDED, PLEASE REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22877315 ↗
• MalfunctionAug 20, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT OR MANAGER REPORTED A QUALITY ISSUE WITH BARD WOUND DRAINS, SPECIFICALLY INVOLVING WHITE STICKY FOREIGN BODIES. DESCRIBED AS SILICONE SLIVER FOUND ON THE SILICONE TUBING. THESE PARTICLES WERE LOCATED IN VARIOUS PLACES AND MUST BE MANUALLY REMOVED, WHICH WAS BOTH DIFFICULT AND CONCERNING FROM A CLINICAL STANDPOINT. THE TEAM, INCLUDING SURGEONS, WAS UNCOMFORTABLE WITH ANYONE HANDLING THE TUBING ONCE IT WAS BEING INSERTED, DUE TO STERILITY AND SAFETY CONCERNS. PER NOTIFICATION FROM UCC ON 08DEC2025, IT WAS REPORTED THAT FOREIGN WHITE MATERIAL PRESENT IN OPENED RETURNED SAMPLES WAS FOUND DURING SAMPLE EVALUATION ON 15OCT2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22849733 ↗
• MalfunctionAug 4, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT CUSTOMER HAD A SERIOUS CONCERN WITH THE WOUND DRAIN, STATING THAT A COMPONENT OF THE PRODUCT COULD BE EASILY TORN OFF, A PIECE OF THE PRODUCT DID BREAK OFF BASED ON THE PHOTO SAMPLE AVAILABLE POTENTIALLY POSING A PATIENT SAFETY RISK. THIS ISSUE HAD PROMPTED TWO HOSPITALS TO CONSIDER PULLING THE PRODUCT FROM USE IMMEDIATELY. A PREVIOUS RESPONSE IN (B)(6) FROM A FORMER REPRESENTATIVE CLAIMING ¿THERE WAS NOTHING WRONG WITH THE PRODUCT¿ HAD NOT BEEN WELL RECEIVED BY THE SURGEON OR THE HOSPITAL¿S PATIENT SAFETY AND QUALITY DEPARTMENT. PER ADDITIONAL INFORMATION RECEIVED ON 19SEP2025 VIA EMAIL, MAIN COMPLAINT WAS THE SEAM OF PLASTIC AT THE PROXIMAL PORTION OF THE DRAIN HAD EXTRA MATERIAL THAT FLAKED OFF - RECREATED WITH REP PRESENT ON SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22699793 ↗
• MalfunctionDec 30, 2024Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT 7MM FLAT WOUND DRAIN WAS OPENED, IT HAD LOOSE PLASTIC PIECES ALONG THE END OF IT, 2 ADDITIONAL DRAINS WERE OPENED. THE FIRST HAD THE SAME PLASTIC PIECES LOOSE, THE THIRD DRAIN WAS PLACED IN THE PATIENT AND ALL DRAIN WERE OPENED THAT WAY ON TO THE STERILE FIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21034242 ↗
• MalfunctionDec 27, 2024Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT 7MM FLAT WOUND DRAIN WAS OPENED, IT HAD LOOSE PLASTIC PIECES ALONG THE END OF IT, 2 ADDITIONAL DRAINS WERE OPENED. THE FIRST HAD THE SAME PLASTIC PIECES LOOSE, THE THIRD DRAIN WAS PLACED IN THE PATIENT AND ALL DRAIN WERE OPENED THAT WAY ON TO THE STERILE FIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21025803 ↗
• MalfunctionDec 10, 2024

  A 7MM FLAT DRAIN WAS OPENED, IT HAD LOOSE PLASTIC PIECES ALONG THE END OF IT, 2 ADDITIONAL DRAINS WERE OPENED. THE FIRST HAD THE SAME PLASTIC PIECES LOOSE, THE THIRD DRAIN WAS PLACED IN THE PATIENT. ALL DRAINS WERE OPENED THAT WAY ON TO THE STERILE FIELD. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20891675 ↗
• MalfunctionSep 23, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE WOUND DRAIN SHREDDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20279004 ↗
• MalfunctionApr 17, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT WHEN THE SURGEON PULLED OUT THE 7MM HUBLESS SILICONE FLAT WOUND DRAIN AND IT DISCONNECTED FROM THE TUBING AND HAD TO BE REPLACED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19124106 ↗
• InjuryJan 12, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT HAD THE ORIGINAL PAROTIDECTOMY. THEY WENT TO FOLLOW-UP APPOINTMENT AT THE OFFICE WHERE DOCTOR WAS PLANNING ON PULLING THEIR DRAIN THAT WAS LOCATED IN THEIR NECK AND SUTURED BEHIND THEIR EAR. UPON CUTTING THE SUTURE AND PULLING THE DRAIN OUT, ONLY HALF OF THE DRAIN WAS REMOVED. THE WHITE PREFORMATTED PORTION OF THE 7 FR JP DRAIN STAYED INSIDE THE PATIENT. THEY STATED THAT WHILE AT HOME AFTER DISCHARGE, THE JP BULB WOULD NOT HOLD A SUCTION, WHICH WAS EVIDENCE THERE WAS A PROBLEM WITH THE DRAIN. PATIENT RETURNED FOR REMOVAL OF RETAINED DRAIN IN OPERATING ROOM. DRAIN WAS REMOVED AND SENT TO PATHOLOGY.

  Patient problems: Foreign Body In Patient

  MAUDE report 18502000 ↗
• InjuryJan 8, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT 2 DAYS POST SURGERY, PATIENT WENT IN TO GET DRAIN REMOVED IN DOCTOR OFFICE AND THE TUBE BROKE WHEN THE SUTURES WERE CUT. THE CLEAR PART CAME OUT BUT WHITE PART REMAINED. SURGERY PLACEMENT DATE (B)(6) 2023 PAROTID ARTERY REMOVAL AND DRAIN PLACED, AFTER THAT PATIENT WENT BACK TO SURGERY TO HAVE REMAINING TUBE REMOVED ON (B)(6) 2023, PATIENT SO FAR WAS OK AFTER REMOVAL. THEY HAD TO HAVE TUBE REMOVED SURGICALLY. SAMPLE WAS IN PATHOLOGY BUT AVAILABLE. PER SAMPLE FORM RECEIVED ON 23JAN2024, STICKERS ON DRAIN. ADDITIONAL SURGERY TO REMOVE DRAIN AND SECOND SURGERY FOREIGN BODY REMOVAL. NO, THE DEVICE REPLACED. DRAIN PULLED IN OFFICE, WHITE PERFORATED PORTION REMAINED IN PATIENT NECK. THE PATIENT RETURNED TO OPERATION ROOM TO HAVE REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18465553 ↗
• InjuryOct 30, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WOUND DRAIN SNAPPED UPON REMOVAL AND LEFT A PORTION IN THE PATIENT. PATIENT HAD TO RETURN TO SURGERY TO REMOVE REMAINING PORTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 18028816 ↗
• InjuryFeb 3, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE 7 ML FLAT DRAIN BROKE INSIDE THE PATIENT DURING INSERTION. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13445709 ↗
• MalfunctionSep 27, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE WOUND DRAIN BROKEN DURING REMOVAL. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12532465 ↗
• MalfunctionSep 23, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WOUND DRAIN APPEARED TO BE IN TWO PIECES UPON REMOVAL. NO RESISTANCE WITH REMOVAL AND NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12520086 ↗
• MalfunctionSep 10, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT SOME OF 7 MM HUBLESS, SILICONE, FLAT DRAIN, WITH FULL PERFORATION WOUND DRAINS WERE BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12455567 ↗
• InjuryJul 15, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE FUSION AND FIXATION OF L2 AND L3 SURGICAL PROCEDURE ON (B)(6) 2021. UPON POST OPERATIVE FOLLOW-UP ON (B)(6) 2021 IT WAS REVEALED VIA IMAGING THAT A PART OF THE DRAIN PULLED ON THE DAY OF DISCHARGE WAS RETAINED. THE REMAINING PART WAS SURGICALLY REMOVED ON (B)(6) 2021. IT WAS STATED THAT THE PATIENT RETAINED A SIGNIFICANT PORTION OF THE DRAIN ON (B)(6) 2021.

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

  MAUDE report 12174903 ↗
• InjuryAug 6, 2018Break; Entrapment of Device; Device Contamination with Chemical or Other Material; Physical Resistance/Sticking; Break

  IT WAS REPORTED THAT UPON INSPECTION OF THE CHANNEL DRAIN AFTER REMOVAL IT APPEARED VERY SHORT WITH A JAGGED EDGE. THE NURSE RECEIVED ORDERS TO REMOVE THE DRAIN FROM THE PHYSICIAN. AFTER REMOVING THE STITCHES, THE NURSE SLOWLY REMOVED THE DRAIN WITHOUT ENCOUNTERING ANY RESISTANCE. A CT SCAN WAS DONE AND CONFIRMED THAT THERE WAS FOREIGN MATTER APPROXIMATELY 3.7 CM DEEP. THE PATIENT WAS TAKEN TO SURGERY ON (B)(+) 2018. THE SUPERIOR 2.5 CM OF THE WOUND WAS OPENED AND THE AREA AS INSPECTED, BUT THE FOREIGN MATERIAL COULD NOT BE FOUND. ONE OF THE SUPERIOR MOST FASCIAL SUTURES WAS CUT EXPOSING THE SUBFASCIAL COMPARTMENT. AT THAT POINT THE FOREIGN PIECE OF MATERIAL WAS IDENTIFIED. THERE WERE NOT ANY SUTURES RUNNING THROUGH THE FOREIGN MATERIAL, HOWEVER THE PIECE APPEARED TO BE SEVERED OFF AT THE LEVEL OF ONE OF THE FASCIAL STITCHES. THE FOREIGN MATERIAL WAS EASILY REMOVED AND THE PATIENT WAS DISCHARGED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7752232 ↗
• MalfunctionJul 30, 2018Misassembled; Material Integrity Problem; Misassembled

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

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

  MAUDE report 7731938 ↗
• InjuryMay 15, 2018Break; Break; Material Perforation

  IT WAS REPORTED THAT A PATIENT HAD THE DRAIN PLACED INTRA-OPERATIVELY FOLLOWING A LAPAROSCOPIC CHOLECYSTECTOMY ON (B)(6) 2018. ON (B)(6) 2018, THE DRAIN WAS REMOVED; HOWEVER, THE PERFORATED PORTION OF THE DRAIN REMAINED IN THE ABDOMEN. THE PATIENT WAS SENT FOR AN ABDOMINAL FILM ON (B)(6) 2018, AND LEARNED THAT THE PERFORATED PORTION OF THE DRAIN WAS IDENTIFIED ON THE FILM. THE DOCTOR SCHEDULED THE PATIENT FOR A FOREIGN BODY RETRIEVAL ON (B)(6) 2018.

  Patient problems: Foreign Body In Patient

  MAUDE report 7515025 ↗
• MalfunctionApr 23, 2018Sticking; Self-Activation or Keying; Sticking

  IT WAS REPORTED THAT THE INNER PACKAGE OF THE FLAT SILICONE DRAIN WAS NOT SEALED ON ITS OWN AND WAS INSTEAD SEALED TO THE SEAMS OF THE OUTER PACKET.

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

  MAUDE report 7453091 ↗
• MalfunctionApr 23, 2018Misassembled; Misassembled; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE FLAT SILICONE WOUND DRAIN DID NOT HAVE THE CORRECT NUMBER OF PERFORATIONS.

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

  MAUDE report 7452925 ↗
• MalfunctionApr 23, 2018Misassembled; Misassembled; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE FLAT SILICONE WOUND DRAIN DID NOT HAVE THE CORRECT NUMBER OF PERFORATIONS.

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

  MAUDE report 7452922 ↗