BLAKE 2233Recalls & reported problems

Summary

The FDA's MAUDE database contains 114 adverse event reports that list this exact device (DI 10705031003613), received between Dec 21, 2017 and Sep 15, 2026 — classified as 16 injuries, 98 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (30 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 114 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Material Integrity Problem

  It was reported that a patient underwent an unknown procedure on an unknown date and a drain was used. During the procedure, the drain had adhered to the trocar needle. Another product was used to complete the case. There were no adverse consequences to the patient. Upon evaluation of the device returned, the received displayed evidence of adherence of the drain to the trocar.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50772634 ↗
• MalfunctionJun 15, 2026Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND A DRAIN WAS USED. THE DRAIN HAD ADHERED TO THE TROCAR NEEDLE AND THE DRAIN WAS DAMAGED WHEN SEPARATED THEM. THIS EVENT WAS FOUND BEFORE USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. UPON RECEIPT AND EVALUATION, A STICKY MARK OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25504003 ↗
• MalfunctionJun 8, 2026Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND A DRAIN WAS USED. THE DRAIN HAD BEEN ADHERED TO THE BENDABLE TROCAR NEEDLE, AND WHEN THEY WERE SEPARATED, A FOREIGN MATTER REMAINED INSIDE THE DRAIN LUMEN. THE PRODUCT WAS NOT USED FOR THE PATIENT, SO THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. FURTHER DETAILS ARE NOT PROVIDED. UPON RECEIPT AND ANALYSIS, STICKING MARK WAS FOUND AND CHIP MARKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25435868 ↗
• MalfunctionMay 7, 2026Obstruction of Flow

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2026 AND A DRAIN WAS USED. IT COULD NOT SUCK EXUDATE AFTER THE DRAIN WAS INSERTED. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THE PRODUCT HAS BEEN DISCARDED. 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 25116084 ↗
• MalfunctionMay 7, 2026Obstruction of Flow

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2026 AND A DRAIN WAS USED. IT COULD NOT SUCK EXUDATE AFTER THE DRAIN WAS INSERTED. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THE PRODUCT HAS BEEN DISCARDED. 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 25116047 ↗
• MalfunctionApr 29, 2026Leak/Splash

  IT WAS REPORTED A PATIENT UNDERWENT A SPINAL SURGERY ON AN UNKNOWN DATE AND A DRAIN WAS USED. THE DRAIN WAS INSERTED BEFORE WOUND CLOSURE AND THE PROCEDURE APPEARED TO HAVE BEEN PERFORMED CORRECTLY, BUT THERE WAS A SOUND LIKE AN AIR LEAK AND THE RESERVOIR COULD NOT SUCK EXUDATE WHEN CONNECTED TO THE BAG AND STARTING TO DRAW FLUID. THE DOCTOR SAID THAT THIS HAS NEVER HAPPENED BEFORE. 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 25028261 ↗
• MalfunctionApr 29, 2026Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN UROLOGICAL SURGERY ON (B)(6) 2026 AND DRAIN WAS USED. WHEN THE PACKAGE WAS OPENED, IT WAS FOUND THAT THE DRAIN HAD BEEN ADHERED TO THE NEEDLE. WHEN THEY WERE SEPARATED, IT WAS FOUND THAT THERE WAS DAMAGE TO THE DRAIN PART. 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 25027777 ↗
• MalfunctionApr 21, 2026Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN UROLOGICAL SURGERY ON 23-JAN-2026 AND A DRAIN WAS USED. DURING SURGERY, WHEN THE PRODUCT WAS USED, THE STERILE PACKAGE WAS OPENED AND CONFIRMED THE PRODUCT, IT WAS FOUND THAT THE TROCAR AND THE DRAIN HAD BEEN ADHERED. WHEN THE ADHERED PART WAS REMOVED BY HAND, THE ADHERED PART OF THE DRAIN CAME OFF. 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, STICKED MARKS WERE VISIBLE ON THE TROCAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24941172 ↗
• MalfunctionApr 20, 2026Infusion or Flow Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND A DRAIN WAS USED. THE DRAIN WAS DAMAGED AFTER NEGATIVE PRESSURE WAS APPLIED, THE BAG OPENED AND BECAME UNUSABLE. 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 24930685 ↗
• InjuryApr 16, 2026Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A DRAIN WAS USED. MD ATTEMPTED TO DISCONTINUE DRAIN FROM PATIENT'S RIGHT UPPER CHEST. THE DRAIN TUBING BROKE DURING REMOVAL, LEAVING A PORTION OF THE TUBE INSIDE THE PATIENT. MDS EXPLAINED THE SITUATION TO THE PATIENT. SITE DRESSED BY THE MDS. PATIENT REQUIRED SURGICAL INTERVENTION TO RETRIEVE BROKEN OFF PIECE OF DRAIN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24897350 ↗
• MalfunctionMar 9, 2026Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE A DRAIN WAS USED. THE TROCAR NEEDLE WAS UNUSUALLY BENT. 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, BENT CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24546301 ↗
• MalfunctionMar 6, 2026Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN ORTHOPEDIC SURGERY ON (B)(6) 2025 AND DRAIN WAS USED. WHEN THE NURSE OPENED THE PACKAGE DIRECTLY BEFORE USE, IT WAS FOUND THAT THE DRAIN AND THE TROCAR NEEDLE HAD 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, A BLUE STICKING MARKS ON THE TROCAR WAS VISIBLE AND A CHIP-OFF MARK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24532036 ↗
• InjuryFeb 27, 2026Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2025 AND A DRAIN WAS USED. A DRAIN EXCHANGE USING A GUIDEWIRE WAS PLANNED IN THE FLUOROSCOPY ROOM. HOWEVER, DURING THE EXAMINATION, IT WAS FOUND THAT THE DRAIN WAS COMPLETELY DISCONNECTED BEHIND THE STERNUM. (IN RETROSPECT, IT ALREADY APPEARED TO BE CUT ON THE CHEST X-RAY TAKEN ON (B)(6).) AFTER LOCAL ANESTHESIA ALONG THE DRAINAGE SITE AT THE CENTER OF THE CLAMSHELL INCISION, A 4-CM SMALL INCISION WAS MADE, AND GRASPING WITH PEAN FORCEPS UNDER FLUOROSCOPY WAS ATTEMPTED, BUT IT WAS DIFFICULT. IT WAS JUDGED THAT THE PROCEDURE SHOULD BE PERFORMED IN THE DSA ROOM WITH SUFFICIENT SEDATION AND ANALGESIA. AFTER MOVING TO THE DSA ROOM, SURGERY WAS STARTED UNDER GENERAL ANESTHESIA. PEAN FORCEPS WERE INSERTED FROM THE INTERCOSTAL SPACE AT THE RIGHT LOWER EDGE OF THE STERNUM (NEAR THE STERNUM THAT HAD BEEN TRANSECTED DURING THE FIRST SURGERY), AND WHILE CHECKING FLUOROSCOPY, THE TIP OF THE DISCONNECTED DRAIN WAS SUCCESSFULLY GRASPED AND REMOVED. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. FURTHER DETAILS ARE NOT PROVIDED ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24469126 ↗
• MalfunctionJan 6, 2026Infusion or Flow Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A DRAIN WAS USED. DURING THE PROCEDURE, CLOGGING OCCURRED INSIDE OF THE DRAIN. ANOTHER DRAIN WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23975722 ↗
• InjuryDec 22, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A DRAIN WAS USED. IT WAS STATED THAT STAFF ATTEMPTED TO REMOVE JP DRAIN FROM THE PATIENT'S ABDOMEN. ON SLIGHT TUGGING/PULLING THE JP SNAPPED AND RETRACTED BACK TO PATIENT'S ABDOMINAL CAVITY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23865113 ↗
• MalfunctionDec 15, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A DRAIN WAS USED. WHEN CONNECTING AS USUAL, AND AT THE TIME OF SENDING THE PATIENT TO THE WARD, THE RESERVOIR SWELLED FULLY. ALTHOUGH TAKING OUT THE AIR, THE RESERVOIR SWELLED IMMEDIATELY. THE REPORTED PRODUCT WAS USED TO COMPLETE THE CASE. THE PRODUCT REMAINS IN THE PATIENT AND IS BEING USED CONTINUOUSLY, WITH AIR BEING FREQUENTLY RELEASED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23801868 ↗
• MalfunctionDec 2, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A DRAIN WAS USED. DURING THE PROCEDURE, THE SUCTION COULD NOT BE DONE AFTER USE, SO WHEN THE DRAIN WAS CHECKED, THERE WAS A HOLE 15 TO 20 CENTIMETERS FROM THE TROCAR. IT COULD NOT BE PLACED AGAIN, SO THE TROCAR WAS KEPT USING AS IT IS BY STICKING SOMETHING LIKE A FILM (TAPE). SUCTION COULD BE DONE, SO THE CUSTOMER DECIDED TO CONTINUE USING IT. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23692195 ↗
• MalfunctionSep 19, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDEWRENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND A DRAIN WAS USED. THE DRAIN WERE STUCK TOGETHER AND DID NOT COME OFF. FURTHER DETAILS ARE NOT PROVIDED THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. UPON EVALUATION IT WAS OBSERVED A CUT MARK VISIBLE ON THE DRAIN SURFACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23095426 ↗
• MalfunctionSep 2, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2025 AND A DRAIN WAS USED. THE CRACK WAS FOUND DURING USE TO THE PATIENT BUT IT COULD NOT BE REMOVED AND THE CRACKED PART WAS PROTECTED AND USED. (DR'S DECISION) 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 22939628 ↗
• MalfunctionAug 28, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND A DRAIN WAS USED. THE DRAIN HAD ADHERED TO THE TROCAR NEEDLE AND THEY WERE STICKY WHEN THE PRODUCT WAS TAKEN OUT AFTER THE PACKAGE WAS OPENED. THIS EVENT WAS FOUND BEFORE USE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WAS NO PROBLEM TO THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. UPON RECEIPT AND EVALUATION THE DRAIN HAD CHIP-OFF MARKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22911283 ↗
• MalfunctionAug 21, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN OB-GYN SURGERY ON (B)(6) 2025 AND A DRAIN WAS USED. THE DRAIN HAD ADHERED TO THE TROCAR NEEDLE AND TWO HOLES WERE CREATED WHEN SEPARATED THEM. IT WAS NOT USED. 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 IT WAS OBSERVED DRAIN HAD A CHIP-OFF MARK ON UPPER SURFACE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22863945 ↗
• MalfunctionAug 21, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND A DRAIN WAS USED. THE DRAIN HAD ADHERED TO THE TROCAR NEEDLE WHEN THE PACKAGE WAS OPENED AND TRIED TO USE. A HOLE WAS CREATED WHEN SEPARATED THEM. 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, THE DRAIN WAS OBSERVED TO HAVE A STICKING MARK VISIBLE ON TROCAR, ALSO THE DRAIN HAD SIMILAR CHIP-OFF MARK ON UPPER SURFACE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22860195 ↗
• MalfunctionAug 6, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND A DRAIN WAS USED. THE DOCTOR POINTED OUT THAT THE CONNECTION WAS LOOSER THAN OTHER LOTS. THE DOCTOR ALSO SAID THAT THE CONNECTION WAS FIXED WITH SILK SUTURE, BUT AIR STILL GOT SUCKED IN. SAME 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 22731413 ↗
• MalfunctionAug 6, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND A DRAIN WAS USED. THE DOCTOR POINTED OUT THAT THE CONNECTION WAS LOOSER THAN OTHER LOTS. THE DOCTOR ALSO SAID THAT THE CONNECTION WAS FIXED WITH SILK SUTURE, BUT AIR STILL GOT SUCKED IN. SAME 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 22731409 ↗
• MalfunctionAug 6, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND A DRAIN WAS USED. THE DOCTOR POINTED OUT THAT THE CONNECTION WAS LOOSER THAN OTHER LOTS. THE DOCTOR ALSO SAID THAT THE CONNECTION WAS FIXED WITH SILK SUTURE, BUT AIR STILL GOT SUCKED IN. SAME 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 22731403 ↗