Silicone Round DrainRecalls & reported problems across all models

We found 7 models of Silicone Round Drain by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 73 adverse event reports in the FDA's MAUDE database, received between Jan 4, 2018 and May 17, 2026 — classified as 25 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Break” (13 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Silicone Round Drain problems

Silicone Round Drain models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Silicone Round Drain 0070310

  CATHETER, IRRIGATION
  34 reports
• Silicone Round Drain 0070320

  CATHETER, IRRIGATION
  12 reports
• Silicone Round Drain 0070210

  CATHETER, IRRIGATION
  8 reports
• Silicone Round Drain 0070220

  CATHETER, IRRIGATION
  7 reports
• Silicone Round Drain 0070230

  CATHETER, IRRIGATION
  6 reports
• Silicone Round Drain 0070330

  CATHETER, IRRIGATION
  4 reports
• Silicone Round Drain 0070200

  CATHETER, IRRIGATION
  2 reports

Recent Silicone Round Drain adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE SPD DEPARTMENT FOUND, UPON PULLING CASES, THAT A FEW OF THE TUBES HAD BLACK DOTS ON THEM (NOT ALL PACKAGES). ADDITIONAL PRODUCTS UNDER ANOTHER REFERENCE NUMBER WERE ALSO NOTED TO HAVE BLACK DOTS ALONG THE TUBING. IT WAS FURTHER REPORTED THAT REF (B)(4) HAD THESE BLACK DOTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25196453 ↗
• MalfunctionMay 17, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE SPD DEPARTMENT FOUND, UPON PULLING CASES, THAT A FEW OF THE TUBES HAD BLACK DOTS ON THEM (NOT ALL PACKAGES). ADDITIONAL PRODUCTS UNDER ANOTHER REFERENCE NUMBER WERE ALSO NOTED TO HAVE BLACK DOTS ALONG THE TUBING. IT WAS FURTHER REPORTED THAT BOTH REF 070210AND 070310 HAD THESE BLACK DOTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25196442 ↗
• MalfunctionMar 23, 2026Material Fragmentation

  IT WAS REPORTED THAT WHILE STRIPPING THE WOUND DRAIN, REGISTERED NURSE PLACED ONE HAND AT TOP OF DRAIN AND WITH THE VERY FIRST PULL TO STRIP THE DRAIN SNAPPED IN HALF. BLOOD PATHOGEN EXPOSURED TO STAFF. PER FOLLOW-UP INFORMATION RECEIVED VIA EMAIL 28APR2026, PLEASE ADD THE ADDITIONAL PATIENT QUALIFIERS TO THE COMPLAINT: MALE, 35M 127KG, AFRICAN AMERICAN, 70.98¿. MEDICAL INTERVENTION WAS NOT REQUIRED AS, "PA OK WITH DRAIN REMOVAL AT THIS TIME BUT NORMALLY WOULD HAVE REMAINED IN PLACE UNTIL THE AM." NO ADDITIONAL INFORMATION IS AVAILABLE. NO SAMPLE IS AVAILABLE. ONCE THIS INFORMATION HAS BEEN ASSESSED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 24664972 ↗
• MalfunctionFeb 23, 2026Complete Blockage

  IT WAS REPORTED THAT DURING USE THE WOUND DRAIN WAS FOUND TO BE BLOCKED BY HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24421912 ↗
• 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 ↗
• MalfunctionJun 2, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE WOUND DRAIN WAS BROKEN WHEN THE NURSE REMOVED THE DRAIN FROM PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22123546 ↗
• 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 ↗
• InjuryMar 7, 2025Decrease in Suction; Decrease in Suction

  IT WAS REPORTED THAT THE INCIDENT REPORT WAS FILED ON AS THEY HAD TO RETURN TO SURGERY FOR A HEMATOMA EVACUATION BECAUSE THE DRAIN DID NOT WORK AS IT SHOULD HAVE. THIS IS NOT THE FIRST PATIENT THAT THEY HAD THIS PROBLEM WITH. THIS COMPLAINT IS FOR PRODUCT (PCN #(B)(4)) AND (PCN #(B)(4)).

  Patient problems: Hematoma

  MAUDE report 21547545 ↗
• MalfunctionFeb 10, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THEY HAD AN END USER WHO HAD BEEN HAVING ISSUES WITH THE MFG# 0070310.THE NURSE WAS MILKING THE WOUND DRAIN AND THE TUBING SNAPPED IN THE MIDDLE WHERE THE NURSE WAS MILKING THAT. THAT HAD HAPPENED ON TWO OCCASIONS. PER CUSTOMER VIA PHONE ON 05FEB2025, IT WAS REPORTED THAT THE DEVICE HAD BEEN THROWN AWAY. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21346233 ↗
• MalfunctionFeb 10, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THIS ISSUE HAD HAPPENED 2X IN WOUND DRAIN TROCARS. THE NURSE WAS MILKING THE DRAIN AND THE TUBING SNAPPED IN THE MIDDLE WHERE THEY WERE MILKING WOUND DRAINS. PER CUSTOMER VIA PHONE ON 05FEB2025, IT WAS REPORTED THAT THE DEVICE HAD BEEN THROWN AWAY. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21343301 ↗
• MalfunctionDec 31, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE LITTLE PEBBLES WERE FOUND INSIDE THE WOUND DRAIN PACKAGE WHILE PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047206 ↗
• 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 ↗
• MalfunctionDec 13, 2024Wrong Label; Wrong Label

  IT WAS REPORTED THAT WOUND DRAIN WAS SUPPOSED TO BE 1/8 INCH BUT CAME AS 3/16 INCH. THE PACKAGING STATED IT SHOULD BE 1/8 INCH. CUSTOMER HAD 2 CAME IN THIS WAY WITH THE SAME LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20925351 ↗
• 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 ↗

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