BLAKE 2234Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705031003620), received between May 27, 2020 and Mar 18, 2026 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2026Break

  ISSUE WITH BLAKE SILICONE DRAINS.

  Patient problems: Insufficient Information

  MAUDE report 24625913 ↗
• MalfunctionMay 29, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED A PATIENT UNDERWENT A CORONARY ARTERY BYPASS AND AORTIC VALVE REPLACEMENT ON (B)(6) 2025 AND A DRAIN WAS USED. HAIR FOUND IN THE PACKAGE OF DRAIN CHEST TUBE. NO OTHER DETAILS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22104879 ↗
• InjuryNov 30, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT ABDOMINAL AORTIC ANEURYSM -AAA ON (B)(6) 2023 AND A DRAIN WAS USED. IN THE WARD / ICU, THE PRODUCT BROKE INSIDE THE BODY CAVITY. THE DETAILS ARE THE FOLLOWING. THE PRODUCT WAS USED ON (B)(6), AND THE DRAIN WAS PLACED. JUDGMENTS WERE MADE BASED ON CT IMAGES UNTIL ON (B)(6), BUT THERE DID NOT APPEAR TO BE ANY DAMAGE TO THE PRODUCT. ON (B)(6), THERE WAS A POSSIBILITY OF RUPTURE. WHEN THE PRODUCT WAS REMOVED ON (B)(6), IT WAS CONFIRMED THAT THE PRODUCT WAS BROKEN. THEREFORE, THE PATIENT WAS GIVEN GENERAL ANESTHESIA AND THE DRAIN WAS REMOVED. THE SURGEON SUGGESTED SOME POSSIBILITIES. THERE WAS A POSSIBILITY THAT THE SUTURE USED TO SECURE THE DRAIN HAD BEEN WRAPPED AROUND THE ENTIRE CIRCUMFERENCE OF THE DRAIN. ALSO, (NORMALLY, THE DRAIN IS PLACED CLOSER TO THE NAVEL THAN THE FLANK TO AVOID PUTTING TENSION ON IT), BUT IN THIS CASE, BECAUSE THE PATIENT HAD A HIGH BMI, THE DRAIN WAS INSERTED FROM THE FLANK, CREATING LIKE A "HAIRPIN CURVE" SHAPE AS IT WAS LEFT IN PLACE, AND THERE WAS A POSSIBILITY THAT IT WOULD BE UNDER TENSION AND BREAK WHEN IT WAS REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18236060 ↗
• MalfunctionMay 3, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2023 AND A DRAIN WAS USED. AFTER OPENING THE PACKAGE AND BEFORE USE, IT WAS FOUND THAT THERE WAS A HAIR IN THE STERILE PACKAGE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16862877 ↗
• MalfunctionMay 3, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED, A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND A DRAIN WAS USED. SUCTION COULD NOT BE DONE PROPERLY. FURTHER DETAILS ARE NOT PROVIDED. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16861316 ↗
• MalfunctionMay 1, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND A RESERVOIR WAS USED. SUCTION COULD NOT BE DONE PROPERLY. FURTHER DETAILS ARE NOT PROVIDED. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16842964 ↗
• MalfunctionApr 27, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED A PATIENT UNDERWENT A PANCREATICODUODENECTOMY ON (B)(6) 2023 AND A DRAIN WAS USED. IN THE WARD / ICU, SUCTION COULD NOT BE DONE PROPERLY. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16828095 ↗
• InjurySep 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A LAPAROSCOPIC PYELOPLASTY ON (B)(6) 2022 AND A DRAIN WAS USED. PATIENT TAKEN TO SURGERY, AT THE TIME OF REMOVAL OF THE DEVICE A EPIPLOCELE DEVELOPED . A REVISION SURGERY DONE ON (B)(6) 2022 TO REDUCE EPIPLOCELE UNDER LOCAL ANESTHESIA ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Hernia

  MAUDE report 15514227 ↗
• MalfunctionDec 8, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED A PATIENT UNDERWENT AN ESOPHAGEAL SURGERY ON (B)(6) 2021 AND A DRAIN WAS USED. DURING SURGERY AN AIR LEAK OCCURRED. ON (B)(6), AFTER COMPLETION OF CHEST OPERATION, THE DEVICE WAS PLACED IN THE CHEST CAVITY. WHEN THE DRAIN WAS FIXED TO THE SKIN AT THE BLACK SPOT MARK, AIR LEAK OCCURRED. SO, ANOTHER 24 FR DRAIN WAS USED. IT WAS COMMENTED THAT SINCE THE PATIENT WAS GOOD BUILD, THE GROOVES OF THE DRAIN MIGHT HAVE BEEN COMING OUT OF THE BODY SURFACE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12961074 ↗
• MalfunctionMay 27, 2020Suction Problem; Suction Problem

  IT WAS REPORTED A PATIENT AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6) 2020 AND A DRAIN WAS USED. DURING SURGERY THE DRAIN WAS CLOGGED THOUGH IT WAS NEW. THE LOT NUMBER IS UNKNOWN. FURTHER DETAILS ARE NOT PROVIDED. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10094295 ↗