Silicone Flat DrainRecalls & reported problems across all models

We found 5 models of Silicone Flat Drain by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 96 adverse event reports in the FDA's MAUDE database, received between Apr 24, 2017 and Jan 21, 2026 — classified as 33 injuries, 63 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (23 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 Flat Drain problems

Silicone Flat Drain models

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

• Silicone Flat Drain 0070370

  CATHETER, IRRIGATION
  29 reports
• Silicone Flat Drain 0070440

  CATHETER, IRRIGATION
  29 reports
• Silicone Flat Drain 0070430

  CATHETER, IRRIGATION
  27 reports
• Silicone Flat Drain 0070360

  CATHETER, IRRIGATION
  10 reports
• Silicone Flat Drain V0070440

  CATHETER, IRRIGATION
  1 report

Recent Silicone Flat Drain adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionJan 9, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AFTER PRODUCT OPENING WHITE FOREIGN MATTER WAS FOUND ADHERING TO THE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24030620 ↗
• MalfunctionJan 5, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT UPON INSPECTION OF THE WOUND DRAIN BEFORE USE, THE TUBE HAD DIRT AND CRACKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23970201 ↗
• 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 ↗
• 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 ↗
• MalfunctionNov 21, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BEFORE USE, TUBE WAS NOT USED BECAUSE WHITE FOREIGN MATTER WAS FOUND ON THE SHAFT PORTION OF THE WOUND DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619455 ↗
• MalfunctionOct 20, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE CUSTOMER STATED FOREIGN MATTER (INSIDE THE STERILIZED PACKAGE), FRACTIONAL GOOD PRODUCT, BIOLOGICAL MATTER (INSIDE THE STERILIZED PACKAGE) FOREIGN MATTER (OUTSIDE THE STERILIZED PACKAGE) BIOLOGICAL MATTER (INSIDE THE STERILIZED PACKAGE) FRACTIONAL GOOD PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335348 ↗
• MalfunctionOct 17, 2025Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping; Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE CUSTOMER STATED FOREIGN MATTER (INSIDE THE STERILIZED PACKAGE) FRACTIONAL GOOD PRODUCT BIOLOGICAL MATTER (INSIDE THE STERILIZED PACKAGE) FOREIGN MATTER (OUTSIDE THE STERILIZED PACKAGE) BIOLOGICAL MATTER (INSIDE THE STERILIZED PACKAGE) FRACTIONAL GOOD PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23328401 ↗
• MalfunctionOct 15, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE TUBE OF THE WOUND DRAIN WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23290746 ↗
• 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 29, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A WHITE FLAKY SUBSTANCE WAS ADHERING TO THE WOUND DRAIN TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23167097 ↗
• MalfunctionSep 23, 2025Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT ON 16SEP2025, WHEN THE WOUND DRAIN PRODUCT WAS OPENED IN THE OPERATING ROOM, A BURR WAS FOUND, AND IT WAS DISCONTINUED. WHEN A PRODUCT FROM THE SAME LOT WAS OPENED, A BURR WAS ALSO FOUND, AND IT WAS DISCONTINUED FROM USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23123078 ↗
• InjurySep 22, 2025Material Too Soft/Flexible; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE FOUR NEURO SURGERY CASES AT (B)(6) HOSPITAL HAVE EXPERIENCED COMPLICATIONS DUE TO ISSUES WITH THE 10 MM FLAT DRAIN (PRODUCT CODE: 0070370). THE TUBING IS REPORTEDLY FLIMSY AND PRONE TO CRIMPING, WHICH INTERFERES WITH PROPER INSERTION. IN ONE INSTANCE, THE SURGEON WAS UNABLE TO FULLY PLACE THE DRAIN, RAISING SAFETY CONCERNS. AS A RESULT, FOUR PATIENTS REQUIRED RETURN TRIPS TO THE OR, AND ONE DEVELOPED A HEMATOMA. THE ISSUE APPEARS TO BE LINKED TO A PRODUCT CHANGE THAT OCCURRED OVER THE SUMMER, AND THE HOSPITAL IS CURRENTLY WORKING WITH EMR STAFF TO RETRIEVE THE AFFECTED LOT NUMBERS. FOR FURTHER INVESTIGATION AND RESOLUTION, SAMPLES SHOULD BE SENT TO: PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 05NOV2025, IT WAS REPORTED THAT THE CUSTOMER WAS NOT AWARE OF SPECIFIC HARM, ALL 4 CASES, THAT WERE BROUGHT TO THEIR ATTENTION, HAD THEIR DRAINS DISCONTINUED EARLIER THAN DESIRED. NO LOT NUMBER WAS PROVIDED.

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

  MAUDE report 23110213 ↗
• InjurySep 22, 2025Material Too Soft/Flexible; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE FOUR NEUROSURGERY CASES AT HENRY FORD JACKSON HOSPITAL HAVE EXPERIENCED COMPLICATIONS DUE TO ISSUES WITH THE 10 MM FLAT DRAIN (PRODUCT CODE: 0070370). THE TUBING IS REPORTEDLY FLIMSY AND PRONE TO CRIMPING, WHICH INTERFERES WITH PROPER INSERTION. IN ONE INSTANCE, THE SURGEON WAS UNABLE TO FULLY PLACE THE DRAIN, RAISING SAFETY CONCERNS. AS A RESULT, FOUR PATIENTS REQUIRED RETURN TRIPS TO THE OR, AND ONE DEVELOPED A HEMATOMA. THE ISSUE APPEARS TO BE LINKED TO A PRODUCT CHANGE THAT OCCURRED OVER THE SUMMER, AND THE HOSPITAL IS CURRENTLY WORKING WITH EMR STAFF TO RETRIEVE THE AFFECTED LOT NUMBERS. FOR FURTHER INVESTIGATION AND RESOLUTION, SAMPLES SHOULD BE SENT TO: PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 05NOV2025, IT WAS REPORTED THAT THE CUSTOMER WAS NOT AWARE OF SPECIFIC HARM, ALL 4 CASES, THAT WERE BROUGHT TO THEIR ATTENTION, HAD THEIR DRAINS DISCONTINUED EARLIER THAN DESIRED. NO LOT NUMBER WAS PROVIDED.

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

  MAUDE report 23110190 ↗
• InjurySep 22, 2025Material Too Soft/Flexible; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE FOUR NEURO SURGERY CASES AT HENRY FORD JACKSON HOSPITAL HAVE EXPERIENCED COMPLICATIONS DUE TO ISSUES WITH THE 10 MM FLAT DRAIN (PRODUCT CODE: 0070370). THE TUBING IS REPORTEDLY FLIMSY AND PRONE TO CRIMPING, WHICH INTERFERES WITH PROPER INSERTION. IN ONE INSTANCE, THE SURGEON WAS UNABLE TO FULLY PLACE THE DRAIN, RAISING SAFETY CONCERNS. AS A RESULT, FOUR PATIENTS REQUIRED RETURN TRIPS TO THE OR, AND ONE DEVELOPED A HEMATOMA. THE ISSUE APPEARS TO BE LINKED TO A PRODUCT CHANGE THAT OCCURRED OVER THE SUMMER, AND THE HOSPITAL IS CURRENTLY WORKING WITH EMR STAFF TO RETRIEVE THE AFFECTED LOT NUMBERS. FOR FURTHER INVESTIGATION AND RESOLUTION, SAMPLES SHOULD BE SENT.

  Patient problems: Hematoma

  MAUDE report 23110189 ↗

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