BLAKE 2217Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10705031003538), received between Dec 4, 2018 and Mar 16, 2026 — classified as 11 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Break” (36 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 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A DRAIN WAS USED. IT WAS FOUND THAT THE DRAIN HAD ADHERED TO THE TROCAR NEEDLE. WHEN SEPARATING THEM FORCIBLY, 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, A STICKING MARK ON THE TROCAR WAS VISIBLE AND A CHIP-OFF MARK ON THE UPPER SURFACE OF THE DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24603870 ↗
• MalfunctionDec 26, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND A DRAIN WAS USED. DURING INSERT OPERATION, THE DRAIN WAS BROKEN. ANOTHER PRODUCT 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 23897352 ↗
• InjuryOct 30, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND A DRAIN WAS USED. POST-OP, THE DRAIN BROKE DURING REMOVAL ON D2 OF THE PROCEDURE. THE PATIENT WAS TAKEN BACK TO THE BLOCK FOR REMOVAL OF THE DRAIN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23425336 ↗
• MalfunctionMar 26, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND DRAIN WAS USED. DURING A SURGICAL PROCEDURE, WHILE PLACING THE DRAINAGE, THE DRAIN BROKE AT THE JUNCTION BETWEEN THE FLAT WHITE PART AND THE CLEAR CYLINDRICAL PART. THE PROBLEM HAS OCCURRED RECENTLY -BUT NOT REPORTED AND THE MATERIAL WAS NOT RETAINED. PRECAUTIONARY MEASURES AND ACTIONS UNDERTAKEN: CHANGE OF DRAINAGE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21700966 ↗
• MalfunctionMar 26, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2025 AND DRAIN WAS USED. DURING A SURGICAL PROCEDURE, WHILE PLACING THE DRAINAGE, THE DRAIN BROKE AT THE JUNCTION BETWEEN THE FLAT WHITE PART AND THE CLEAR CYLINDRICAL PART. PRECAUTIONARY MEASURES AND ACTIONS UNDERTAKEN: CHANGE OF DRAINAGE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21700962 ↗
• MalfunctionMar 19, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2025 AND A DRAIN WAS USED. THE HUB PART OF DRAIN WAS BROKEN WHEN PLACING 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 21645637 ↗
• MalfunctionJun 13, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A LAPAROTOMY OF PANCREATICODUODENECTOMY ON AN UNKNOWN DATE AND A DRAIN WAS USED. WHEN THE DRAIN WAS REMOVED AND PULLED IT AT THE END OF THE OPERATION, IT WAS BROKEN JUST UNDER THE SKIN. THERE WAS NO RE-OPERATION AND NO EFFECT ON THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. 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 19529645 ↗
• MalfunctionMay 9, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE A DRAIN WAS BROKEN. WHEN THE PRODUCT WAS OPENED, IT WAS FOUND THAT THE DRAIN HAD BEEN BROKEN. FURTHER DETAILS ARE NOT PROVIDED. 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 19279011 ↗
• InjuryApr 11, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024 AND A DRAIN WAS USED. IN ICU, WHEN TAKING OUT THE DRAIN, THE DRAIN HAD BEEN BROKEN AT THE PART OF ENTRY WOUND. LOCAL ANESTHESIA WAS PERFORMED AS ADDITIONAL TREATMENT, AND SKIN INCISION WAS EXTENDED. AS A RESULT, THE DRAIN COULD BE REMOVED. EXTENSION OF SKIN INCISION. NO LEAK OCCURRED. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19093360 ↗
• MalfunctionMar 21, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A PANCREATICODUODENECTOMY SURGERY WAS PERFORMED ON (B)(6) 2024 AND A DRAIN WAS USED. THE PRODUCT WAS USED ON BILIARY JEJUNAL ANASTOMOSIS. NEXT DAY, DRAINAGE WAS PERFORMED WITHOUT ANY PROBLEMS. AROUND NOON ON (B)(6) , A NURSE NOTICED THAT THE DRAINAGE WAS NOT DONE PROPERLY, AND WHEN THE NURSE TOOK IT OUT, IT WAS FOUND THAT THE PRODUCT HAD COMPLETELY BROKEN INSIDE THE ABDOMINAL CAVITY FROM THE TRIANGULAR JOINT WHERE IT CHANGES FROM FLAT TO ROUND. THE BROKEN PRODUCT WAS RETRIEVED FROM INTRAPERITONEAL. THERE WAS NO PRODUCT RESIDUE IN THE BODY CAVITY AND THERE WAS NO EFFECT ON THE PATIENT, SO NO RE-OPERATION WAS PERFORMED. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18951128 ↗
• MalfunctionMar 21, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A PANCREATICODUODENECTOMY SURGERY WAS PERFORMED ON (B)(6) 2024 AND A DRAIN WAS USED. THE PRODUCT WAS USED ON BILIARY JEJUNAL ANASTOMOSIS. ON THE NIGHT OF FEB 29, IT WAS FOUND THAT DRAINAGE WAS NOT DONE PROPERLY WITH ANOTHER DRAIN. THE PRODUCT WAS BROKEN IN THE ABDOMINAL CAVITY. THERE WAS NO PRODUCT RESIDUE IN THE BODY THIS TIME AS WELL SO NO RE-OPERATION WAS PERFORMED. THERE WAS NO EFFECT ON THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18951126 ↗
• MalfunctionMar 19, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND A DRAIN WAS USED. WHILE THE DRAIN WAS IN PLACE AT THE END OF THE SURGERY, THE DRAIN BROKE WHEN IT WAS PULLED OUT FROM THE ABDOMINAL WALL TO THE EPIDERMIS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18933869 ↗
• MalfunctionMar 1, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2024 AND A DRAIN WAS USED. THE SURGEON WANTED TO PUT THIS DRAINAGE DEVICE (DRAINAGE TUNNELING) FROM THE ABDOMEN TO THE SKIN AND THE DRAIN BROKE BETWEEN THE FLAT SILICONE DRAIN AND THE SUCTION TUBING. NO CONSEQUENCES FOR THE PATIENT. USE OF ANOTHER DRAIN FROM A DIFFERENT LOT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18818014 ↗
• MalfunctionFeb 27, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED BY A SALES REP THAT, DURING A PANCREATICODUODENECTOMY : PD, ONE PRODUCT WAS USED ON THE BACK OF THE PANCREATICOJEJUNOSTOMY. FOUR DAYS LATER, IT WAS FOUND THAT THE JOINT OF THE PRODUCT WAS ALMOST SHREDDED. FORTUNATELY, THE SURGEON MANAGED TO TAKE THE PRODUCT BECAUSE IT WAS SLIGHTLY STUCK ON THE SURFACE OF THE BODY. IT WAS MANAGED DURING THE DAY WITH IKEMAZE POCHETTE. [THE PATIENT DEMOGRAPHICS] 80 YEAR OLD MAN. [CURRENT STATUS OF THE PATIENT] THE PATIENT IS IN THE HOSPITAL. [TREATMENT DETAILS] ONCE THE DRAIN WAS REMOVED, X-RAYS WERE TAKEN TO CHECK FOR RESIDUALS IN THE BODY. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. AFFILIATE REFERENCE NUMBER IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18791154 ↗
• InjuryFeb 16, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND A DRAIN WAS USED. ALMOST COMPLETE SECTION OF THE DRAIN REMAINING INTRA-ABDOMINAL AFTER AN ATTEMPTED ABLATION. NEED TO GO TO THE BLOCK TO REMOVE THIS FRAGMENT LEFT IN PLACE. THE PATIENT UNDERWENT A PASSAGE TO THE OPERATING ROOM IN ORDER TO RETRIEVE THE PART OF THE DRAIN CUT AT ITS REMOVAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18721314 ↗
• InjuryFeb 16, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND A DRAIN WAS USED. BANDAGE RENEWED, TWO DRAINS REMOVED. ONE OF THE DRAINS RUPTURED WHEN I PULLED TO REMOVE IT. THE TIP OF THE DRAIN REMAINED INSIDE THE PATIENT. NEED TO MOVE TO THE BLOCK TO REMOVE THIS FRAGMENT OF DRAIN THAT REMAINED IN PLACE. THE PATIENT UNDERWENT A PASSAGE TO THE OPERATING ROOM IN ORDER TO RETRIEVE THE PART OF THE DRAIN CUT AT ITS REMOVAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18721186 ↗
• MalfunctionFeb 1, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED A PATIENT UNDERWENT A COLORECTAL SURGERY ON (B)(6) 2023 AND A DRAIN WAS USED. IN THE WARD / ICU, THE DRAIN'S CONNECTION WAS RUPTURED. THE BROKEN PART WAS REMOVED FROM THE PATIENT¿S BODY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18624710 ↗
• MalfunctionDec 12, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN PANCREATODUODENECTOMY ON (B)(6) 2023 AND A DRAIN WAS USED. THE DRAIN WAS PLACED. NEXT DAY, IN THE WARD, THE CONNECTION BETWEEN THE TUBE AND THE WHITE DRAIN WAS SPONTANEOUSLY BROKE OFF OUTSIDE OF THE BODY. 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 18311961 ↗
• MalfunctionDec 12, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6). 2023 AND A DRAIN WAS USED. DURING SURGERY, WHEN THE DRAIN WAS REMOVED, THE CONNECTION BETWEEN THE TUBE AND THE DRAIN WAS PULLED OFF (BROKEN). IT HAPPENED OUTSIDE THE BODY. 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 18309414 ↗
• MalfunctionDec 12, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON( B)(6) 2023 AND A DRAIN WAS USED. DURING SURGERY, THE DRAIN WAS PUNCTURED WITH A TROCAR FROM INSIDE THE ABDOMINAL CAVITY AND PULLED, THE CONNECTION BETWEEN THE TUBE AND THE DRAIN WAS PULLED OFF (BROKEN). IT HAPPENED OUTSIDE OF THE BODY. 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 18309409 ↗
• MalfunctionDec 12, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2023 AND A DRAIN WAS USED. DURING SURGERY, THE CONNECTION BETWEEN THE TUBE AND THE SILICONE DRAIN WAS DISCONNECTED WHEN THE TROCAR WAS PUNCTURED FROM THE ABDOMINAL CAVITY AND THE DRAIN WAS REMOVED FROM THE BODY. 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 18309408 ↗
• MalfunctionDec 12, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2023 AND A DRAIN WAS USED. DURING SURGERY, WHEN THE DRAIN WAS PUNCTURED WITH A TROCAR FROM INSIDE THE ABDOMINAL CAVITY AND PULLED, THE CONNECTION BETWEEN THE TUBE AND THE DRAIN WAS PULLED OFF (BROKEN). IT HAPPENED OUTSIDE OF THE BODY. 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 18309407 ↗
• MalfunctionDec 8, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND A DRAIN WAS USED. WHEN THE DRAIN WAS PLACED UNDER THE SUBCUTANEOUS AND THE SURGEON ATTEMPTED TO BRING THE DRAIN OUT TO THE EPIDERMIS, IT BROKE OUTSIDE THE BODY, ALTHOUGH NO FORCE WAS APPLIED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18291491 ↗
• MalfunctionDec 8, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND A DRAIN WAS USED. WHEN THE DRAIN WAS PLACED UNDER THE SUBCUTANEOUS AND THE SURGEON ATTEMPTED TO BRING THE DRAIN OUT TO THE EPIDERMIS, IT BROKE OUTSIDE THE BODY, ALTHOUGH NO FORCE WAS APPLIED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18291488 ↗
• MalfunctionNov 7, 2023Break; Break

  IT WAS REPORTED BY A SALES REP THAT, DURING A LAPAROSCOPIC DISTAL PANCREATECTOMY, THE PRODUCT WAS INSERTED INTO THE BODY. AFTER THE SURGERY, IN THE WARD, IT WAS FOUND THAT THERE WAS A CRACK IN THE DRAIN BECAUSE NEGATIVE PRESSURE WAS DIFFICULT TO APPLY TO THE BOMB RESERVOIR. THERE WAS NO EFFECT ON THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. AFFILIATE REFERENCE NUMBER IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18088605 ↗