BLAKE 2227Recalls & reported problems

Summary

The FDA's MAUDE database contains 331 adverse event reports that list this exact device (DI 10705031003552), received between Dec 13, 2017 and Sep 28, 2026 — classified as 34 injuries, 297 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (99 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 331 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Infusion or Flow Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917144 ↗
• MalfunctionSep 15, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50780810 ↗
• MalfunctionAug 6, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50155881 ↗
• InjuryJul 30, 2026Break

  It was reported a patient underwent an unknown procedure on an unknown date in 2026 and a drain was used. In the Breast Clinic post surgery, The patient was cleaning the outside of the drain, by wiping it down the length and the end snapped off. Drain was discarded and replaced with other. A sample is available, not original. Additional information has been requested.

  Patient problems: Insufficient Information

  MAUDE report 50089956 ↗
• MalfunctionJun 15, 2026Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2026 AND A DRAIN WAS USED. THE DRAIN HAD ADHERED TO THE TROCAR NEEDLE WHEN THE PRODUCT WAS USED. THIS EVENT WAS FOUND BEFORE USE. THERE WAS NO EFFECT ON THE PATIENT. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. UPON RECEIPT AND EVALUATION, THE DRAIN HAD CHIP MARK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25505020 ↗
• MalfunctionJun 8, 2026Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2026 AND A DRAIN WAS USED. IT WAS FOUND THAT THE DRAIN HAD ADHERED TO THE TROCAR NEEDLE DURING USE AFTER OPENING THE PACKAGE. A HOLE WAS CREATED WHEN SEPARATED THEM AND USE WAS STOPPED. THIS EVENT WAS FOUND BEFORE USE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. UPON RECEIPT AND EVALUATION, THE DRAIN HAD CHIP MARK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25434854 ↗
• MalfunctionJun 8, 2026Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2026 AND A DRAIN WAS USED. THE DRAIN HAD ADHERED TO THE TROCAR NEEDLE WHEN THE PRODUCT WAS USED. THIS EVENT WAS FOUND BEFORE USE. THERE WAS NO EFFECT ON THE PATIENT. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. UPON RECEIPT AND EVALUATION, THE DRAIN HAD CHIP MARK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25430435 ↗
• MalfunctionMay 6, 2026Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN NEUROSURGERY ON AN UNKNOWN DATE AND A DRAIN WAS USED. THE DRAIN TUBE WAS DAMAGE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. UPON RECEIPT AND ANALYSIS, A DEEP HOLE ON THE DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25104475 ↗
• MalfunctionMay 5, 2026Material Integrity Problem

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND A DRAIN WAS USED. IT WAS FOUND THAT THERE WAS A HOLE AT THE TIP. THE HOLE AT THE TIP WAS FOUND BEFORE USE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. UPON RECEIPT AND EVALUATION, THE TUBING AREA HAD A CHIP-OFF MARK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25082181 ↗
• MalfunctionApr 24, 2026Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE A DRAIN WAS USED. WHEN THE PRODUCT WAS OPENED, IT WAS FOUND THAT THE DRAIN AND THE TROCAR HAD BEEN ADHERED IN ADVANCE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. UPON RECEIPT AND ANALYSIS, DRAIN HAD CHIP-OFF MARKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24981655 ↗
• MalfunctionApr 20, 2026Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2026 AND A DRAIN WAS USED. DURING SURGERY, IT WAS FOUND THAT THE CONNECTION BETWEEN THE TUBE AND THE TROCAR WAS BROKEN WHEN THE TUBE WAS PULLED FROM OUTSIDE THE PATIENT'S BODY DURING THE OPERATION. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24931247 ↗
• MalfunctionApr 20, 2026Leak/Splash

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2026 AND A DRAIN WAS USED. DURING SURGERY, THE DRAINAGE FLUID LEAKED FROM BETWEEN THE DRAIN AND THE ADAPTER AFTER INSERTING THE DRAIN AND CONNECTING IT TO THE BAG WHEN SUCTION WAS STARTED. THE DAMAGE WAS FOUND WHEN THE DRAIN TUBE WAS CHECKED. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24929858 ↗
• MalfunctionApr 7, 2026Material Integrity Problem

  T WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2025 A DRAIN WAS USED. THE DRAIN AND THE TROCAR NEEDLE WERE ADHERED. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED.UPON RECEIPT AND ANALYSIS, BLUE STICKING MARK VISIBLE ON TROCAR. HAD SIMILAR CHIP-OFF MARK ON UPPER SURFACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800795 ↗
• MalfunctionApr 7, 2026Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN LAPAROSCOPIC ADRENALECTOMY; ON AN UNKNOWN DATE A DRAIN WAS USED. IT WAS FOUND THAT THE DRAIN HAD ADHERED TO THE TROCAR NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. UPON RECEIPT AND ANALYSIS, STICKING MARK WAS FOUND ON THE TROCAR, CHIP-OFF MARKS ON UPPER SURFACE OF THE DRAIN WERE VISIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800600 ↗
• MalfunctionApr 7, 2026Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2026 A DRAIN WAS USED. WHEN THE PRODUCT WAS OPENED, THE TROCAR NEEDLE AND THE DRAIN HAS ADHERED, AND THE DRAIN BREAKAGE OCCURRED. THE PRODUCT WAS NOT USED FOR THE PATIENT. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. UPON RECEIPT AND ANALYSIS, MINOR CHIP-OFF MARKS ON UPPER SURFACE OF THE DRAIN WERE VISIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24799692 ↗
• InjuryApr 7, 2026Leak/Splash

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN ENT (EYES, NOSE, AND THROAT) SURGERY ON (B)(6) 2026 AND A DRAIN WAS USED. IT WAS FOUND IN THE ISU, THE DRAIN HAD NOT BEEN SUCTIONED A FEW MINUTES AFTER THE OPERATION. THE PATIENT'S THYROID GLAND SWELLED BECAUSE IT WAS NOT SUCTIONED. THE DOCTOR NOTICED THAT THE SLIT RAN FROM THE BLACK DOT TO THE BACK SIDE WHEN HE CHECKED THE DRAIN. THE DRAIN WAS REMOVED AND SURGERY PERFORMED UNDER TOTAL ANESTHESIA TO RE-INSERT IT. THE PATIENT IS CURRENTLY FEELING BETTER AND THE DOCTOR SAYS THAT THERE ARE NO PROBLEMS. THE SLIT LOOKED NORMAL, BUT THERE WAS A BLUE DENT 5 CM FROM THE BLACK SPOT ON THE BACK SIDE WHEN THE PRODUCT OF SAME LOT WAS OPENED. JUST TO BE SAFE, THE PRODUCT OF SAME LOT WON'T BE USED AND ONE FROM ANOTHER LOT WILL BE USED. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Swelling/ Edema

  MAUDE report 24799095 ↗
• MalfunctionMar 30, 2026Leak/Splash

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND A DRAIN WAS USED. DURING SURGERY, THE NEGATIVE PRESSURE COULD NOT BE APPLIED, BUT THE NEGATIVE PRESSURE WAS APPLIED AFTER CHANGING THE RESERVOIR. IT WAS FOUND THAT THERE WAS A HOLE IN THE DRAIN TUBE. THE DRAIN TUBE AND RESERVOIR WERE CHANGED. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24730126 ↗
• MalfunctionMar 20, 2026Leak/Splash

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE A DRAIN WAS USED. THE DRAIN HAD ADHERED TO THE BAG WITH STRONG ADHESIVE BUT IT WAS FORCIBLY REMOVED AND USED. IT WAS FOUND THAT AIR HAD ACCUMULATED IN THE BAG AND CAUSED A LEAK AFTER STARTING USE. THE LEAKING AREA IS BETWEEN THE INSIDE AND OUTSIDE OF THE PATIENT'S BODY CAVITY. CURRENTLY, THE LEAKING AREA HAS BEEN TAPED UP, AND THERE HAVE BEEN NO HEALTH PROBLEMS FOR PATIENT. NO SAMPLE WILL BE RETURNED. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24652085 ↗
• MalfunctionMar 19, 2026Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN (B)(6) 2025 A DRAIN WAS USED. WHEN OPENING THE PACKAGE IN THE MIDDLE OF THE SURGERY, IT WAS FOUND THAT THE DRAIN HAD ADHERED TO THE TROCAR NEEDLE, AND WHEN SEPARATING THEM, THE DRAIN GOT A HOLE. THE PRODUCT WAS NOT USED FOR THE PATIENT. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. UPON RECEIPT AND ANALYSIS, STICKING MARK VISIBLE ON TROCAR AND ONE FINE CHIP-OFF MARK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24638065 ↗
• MalfunctionMar 12, 2026Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2025 AND A DRAIN WAS USED. AFTER OPENING THE PACKAGE, IT WAS FOUND THAT THE DRAIN AND THE TROCAR NEEDLE HAD ADHERED. WHEN REMOVING THEM, THE DRAIN GOT A HOLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. UPON RECEIPT AND ANALYSIS, STICKING MARKS VISIBLE ON TROCAR AND FINE CHIP-OFF MARKS WERE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24581528 ↗
• MalfunctionMar 10, 2026Leak/Splash

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2026 AND A DRAIN WAS USED. WHEN WAS OPENED, THERE HAD BEEN A CRACK IN THE MIDDLE, SO THE HOSPITAL CUT OFF THE CRACKED PART AND CONNECTED IT TO THE RESERVOIR. THE ISSUE OCCURRED AFTER OPENING THE PACKAGE (DURING USE). THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24560786 ↗
• MalfunctionMar 2, 2026Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2025 AND A DRAIN WAS USED. THE DRAIN AND THE TROCAR NEEDLE HAVE ADHERED. THE PRODUCT WAS NOT USED FOR THE PATIENT. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. UPON RECEIPT AND ANALYSIS, A STICKING MARK VISIBLE ON TROCAR AND ONE FINE CHIP-OFF MARK ON DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24481485 ↗
• MalfunctionMar 2, 2026Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2025 AND A DRAIN WAS USED. THE DRAIN AND THE TROCAR NEEDLE HAVE ADHERED. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED, UPON RECEIPT AND ANALYSIS OF PRODUCT, DRAIN HAD CHIP-OFF MARKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24481439 ↗
• MalfunctionFeb 26, 2026Infusion or Flow Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2026 AND A DRAIN WAS USED. THERE HAD BEEN A HOLE IN THE CENTER OF DRAIN, AND SUCTIONING THE DRAINED FLUID TO THE RESERVOIR COULD NOT BE DONE WELL. THE PRODUCT WAS NOT USED FOR THE PATIENT. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24460508 ↗
• MalfunctionFeb 26, 2026Infusion or Flow Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2026 AND A DRAIN WAS USED. THERE HAD BEEN A HOLE ON THE DRAIN. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24458189 ↗