BLAKE 2230Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10705031003583), received between Sep 1, 2017 and Sep 24, 2026 — classified as 12 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Device Contaminated During Manufacture or Shipping

  It was reported a patient underwent an unknown procedure on an unknown date and a drain was used. It was found that there was a black dirt on the catheter appearance when opened the package and tried to use it. 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 50881925 ↗
• MalfunctionJan 28, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND A DRAIN WAS USED. AT THE WARDS/ICU, IT WAS FOUND THAT THE DEVICE WAS BROKEN OUTSIDE OF THE BODY PART. HOW IT WAS MANAGED AFTERWARD, THE PRODUCT NAME, AND WHETHER THERE WAS ANY IMPACT ON THE PATIENT ARE STILL BEING CONFIRMED. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO SAMPLE WILL BE RETURNED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24203513 ↗
• MalfunctionDec 17, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND A DRAIN WAS USED. PRIOR TO USE, IT WAS FOUND THAT THERE HAD BEEN A FOREIGN SUBSTANCE CONCEIVABLY HUMAN HAIR IN THE STERILE PACKAGE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THIS PHENOMENON WAS FOUND IN THE OPERATION ROOM BEFORE OPENING THE STERILE PACKAGE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23830433 ↗
• MalfunctionNov 12, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON AN UNKNOWN DATE AND A DRAIN WAS USED. THE DRAIN WAS BROKEN DURING EMPTYING THE RESERVOIR DURING THE SURGERY. THE ROLLER FOR DURING EMPTYING THE RESERVOIR WAS NOT USED AND THE DRAIN WAS BROKEN DURING EMPTYING THE RESERVOIR WITH COTTON WOOL. NO ADDITIONAL PROCEDURES HAVE OCCURRED FOR THE PATIENT. THE DOCTOR THINKS THAT HOW TO USE WAS BAD. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20668034 ↗
• InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A TOTAL LAPAROSCOPIC HYSTERECTOMY ON AN UNKNOWN DATE IN (B)(6) 2024 AND A DRAIN WAS USED. WHEN REMOVED THE DRAIN, THE GREATER OMENTUM HAD PULLED OUT FROM THE WOUND AND HAD NOT FITTED, SO IT HAD TO DO EMERGENCY SURGERY. FURTHER DETAILS ARE NOT PROVIDED . NO SAMPLE WILL BE RETURNED. PATIENT STATUS IS STABLE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19512253 ↗
• InjuryJun 10, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDEWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A DRAIN WAS USED. A PORTION OF CHEST TUBE BROKE APART DURING REMOVAL AND REMAINED IN PATIENT. PATIENT WITH MULTIPLE HEALTH ISSUES, STABLE. CLINICIAN SEE NO ADVERSE PATIENT IMPACT DUE TO THIS INCIDENT. " NO OTHER DETAILS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19500139 ↗
• MalfunctionFeb 6, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A DRAIN WAS USED. THERE WAS A FOREIGN SUBSTANCE LIKE A HUMAN HAIR IN THE STERILE PACKAGE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18653805 ↗
• MalfunctionOct 4, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A DRAIN WAS USED. THE DRAIN WAS CUT OFF OUTSIDE THE BODY. GAUZE WAS APPLIED AND MILKING WAS PERFORMED MANUALLY, BUT NO MILKING ROLLERS OR OTHER INSTRUMENTS WERE USED. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17872936 ↗
• MalfunctionSep 7, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A DRAIN WAS USED. THE DRAIN WAS CUT OFF OUTSIDE THE BODY. GAUZE WAS APPLIED AND MILKING WAS PERFORMED MANUALLY, BUT NO MILKING ROLLERS OR OTHER INSTRUMENTS WERE USED. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17702028 ↗
• InjuryAug 28, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND A DRAIN WAS USED. PART OF THE PRODUCT THAT WAS REMOVED HAS BEEN DISCARDED. THE BROKEN TIP STILL REMAINS INSIDE THE BODY (INTRATHECAL). THE DRAIN WAS REMOVED AROUND (B)(6) 2023 OF THIS YEAR, AND BECAUSE IT WAS REMOVED WITHOUT ANY DISCOMFORT AT THE TIME OF REMOVAL, THE SURGEON WAS UNAWARE THAT IT REMAINED INSIDE THE BODY. WHEN AN X-RAY WAS PERFORMED ON (B)(6) 2023, THE SURGEON FOUND THAT PART OF THE DRAIN REMAINING IN THE INTRATHECAL. FURTHER DETAILS ARE NOT PROVIDED. NO SAMPLE WILL BE RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17638542 ↗
• InjuryOct 29, 2022Infusion or Flow Problem; Infusion or Flow Problem

  A PATIENT UNDERWENT A PANCREATICODUODENECTOMY ON AN UNKNOWN DATE AND A DRAIN WAS USED. POST-OPERATIVE PATIENT REQUIRED ACCOMMODATION OF 2 DRAINS, WITH TORPID EVOLUTION DUE TO INFECTION OF THE OPERATIVE SITE ORGAN SPACE FOR WHICH HE REQUIRED REINTERVENTION WITH INSERTION OF 2 NEW DRAINS, AFTER THAT DRAINS PERSIST INSUFFICIENT AND DYSFUNCTIONAL FOR WHAT REQUIRED DRAINAGE COLLECTION PERCUTANEOUS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 15695969 ↗
• InjuryOct 29, 2022Infusion or Flow Problem; Infusion or Flow Problem

  A PATIENT UNDERWENT A PANCREATICODUODENECTOMY FOR WHICH REQUIRED REINTERVENTION ON AN UNKNOWN DATE AND A DRAIN WAS USED. POST-OPERATIVE PATIENT REQUIRED REINTERVENTION WITH INSERTION OF 2 NEW DRAINS, AFTER THAT DRAINS PERSIST INSUFFICIENT AND DYSFUNCTIONAL FOR WHAT REQUIRED DRAINAGE COLLECTION PERCUTANEOUS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Failure of Implant

  MAUDE report 15695267 ↗
• InjuryOct 29, 2022Infusion or Flow Problem; Infusion or Flow Problem

  A PATIENT UNDERWENT A PANCREATICODUODENECTOMY ON AN UNKNOWN DATE AND A DRAIN WAS USED. POST-OPERATIVE PATIENT REQUIRED REINTERVENTION WITH INSERTION OF 2 NEW DRAINS, AFTER THAT DRAINS PERSIST INSUFFICIENT AND DYSFUNCTIONAL FOR WHAT REQUIRED DRAINAGE COLLECTION PERCUTANEOUS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Failure of Implant

  MAUDE report 15694887 ↗
• InjuryOct 28, 2022Infusion or Flow Problem; Infusion or Flow Problem

  A PATIENT UNDERWENT A PANCREATICODUODENECTOMY ON AN UNKNOWN DATE AND A DRAIN WAS USED. POST-OPERATIVE PATIENT REQUIRED ACCOMMODATION OF 2 DRAINS, WITH TORPID EVOLUTION DUE TO INFECTION OF THE OPERATIVE SITE ORGAN SPACE FOR WHICH HE REQUIRED REINTERVENTION WITH INSERTION OF 2 NEW DRAINS, AFTER THAT DRAINS PERSIST INSUFFICIENT AND DYSFUNCTIONAL FOR WHAT REQUIRED DRAINAGE COLLECTION PERCUTANEOUS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 15693054 ↗
• MalfunctionApr 22, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND A DRAIN WAS USED. DURING SURGERY, WHEN THE DRAIN WAS USED, THE BREAKAGE WAS FOUND. IT WAS PUT INTO THE BODY ONCE, BUT WHEN THE DAMAGE WAS NOTICED, IT WAS TAKEN OUT AND A NEW PRODUCT WAS APPLIED. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14189713 ↗
• MalfunctionMar 23, 2022Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2022 AND A DRAIN WAS USED. THE DRAIN WAS BROKEN FROM THE BEGINNING. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13860513 ↗
• InjuryMar 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND A DRAIN WAS USED. DURING SURGERY WHEN REMOVING MEDIASTINAL CHEST TUBES RESISTANCE NOTED. ONE OF THE 2 CHEST TUBES WAS STUCK AND UNABLE TO BE PULLED OUT WITHOUT A LOT OF FORCE. PROCEDURE STOPPED, CHEST TUBE CLAMPED AND REMOVED WITH FORCE. UPON REMOVAL DISTAL END OF CHEST TUBE WAS NOTED TO BE KNOTTED. PATIENT EXPERIENCED PAIN WITH REMOVAL. PATIENT GIVEN PRESCRIPTION PAIN MEDICATION. PATIENT REMAINED STABLE THROUGHOUT AND WAS MONITORED CLOSELY POST WITH NO CONCERNS. TYPE OF INCIDENT/PROBLEM: DURING OR AFTER USE. LEVEL OF HARM: NO APPARENT HARM - REACHED PATIENT/PERSON, INCONVENIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Pain

  MAUDE report 13638386 ↗
• InjuryNov 17, 2021Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AND UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2021 AND A DRAIN WAS USED. THE DRAIN SNAPPED DURING REMOVAL OF DRAIN IN THE WARD. PART OF THE DRAIN WAS LEFT IN PATIENT'S ABDOMEN. PATIENT UNDERWENT ADDITIONAL SURGERY TO HAVE THE DRAIN REMOVED. ACCORDING TO THE SURGEON, THERE WERE NO ISSUES WITH THE DRAIN BUT THAT HE MAY HAVE TIGHTENED THE FASCIAL STITCH TOO TIGHTLY WHICH CAUSED DIFFICULTY IN DRAIN REMOVAL, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12829185 ↗
• MalfunctionNov 2, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2021 AND DRAIN WAS USED. DURING SURGERY, DRAIN WAS PERFORATED. ANOTHER PRODUCT THAT WAS IN STOCK WAS USED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12740862 ↗
• InjuryJun 22, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON AN UNKNOWN DATE A DRAIN WAS USED. THE DRAIN WAS CLOGGED AT THE STARTING POINT OF THE GROOVE ON THE DRAIN, AND CARDIAC TAMPONADE DEVELOPED. RE-THORACOTOMY WAS PERFORMED. FURTHER DETAILS ARE NOT PROVIDED. NO SAMPLE WILL BE RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Cardiac Tamponade

  MAUDE report 12040394 ↗
• InjuryAug 24, 2020Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A CABG ON AN UNKNOWN DATE AND A DRAIN WAS USED. POST OPERATIVELY, NURSE ATTEMPTED REMOVE PERICARDIAL DRAIN AS PER PROTOCOL AND RESISTANCE FELT. DOCTOR REVIEWED PATIENT AND INFORMED STAFF THAT DIFFICULT DRAIN REMOVAL WAS EXPECTED DUE TO DIFFICULT INSERTION (SMALL INCISION). DRAIN TUBING SNAPPED ON ATTEMPTED REMOVAL, LEAVING REMAINING PART OF DRAIN TUBE INTERNALLY. THE PATIENT HAD TO RETURN TO SURGERY TO HAVE THE BROKEN PART OF THE DRAIN REMOVED. THE EXTERNAL DRAIN SEGMENT WAS RETAINED FOR COLLECTION. THE INTERNAL DRAIN SEGMENT WAS NOT RETAINED. IT IS UNCLEAR WHETHER THE DRAIN WAS ACCIDENTLY SUTURED IN, AS THE INTERNAL PART OF DRAIN WAS NOT RETAINED POST-REMOVAL. PATIENT HAD AN ADDITIONAL SURGICAL PROCEDURE TO HAVE BROKEN DRAIN SEGMENT REMOVED ¿ RESULTING IN POSSIBLE INCREASED LENGTH OF STAY, AND PROLONGED RECOVERY TIME FROM CUMULATIVE SURGICAL PROCEDURES. PATIENT WAS DOING OK. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient; Not Applicable

  MAUDE report 10446175 ↗
• MalfunctionApr 14, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND A DRAIN WAS USED. BEFORE OPENING THE PACKAGE, IT WAS FOUND THAT THERE HAD BEEN A FOREIGN SUBSTANCE LIKE A HAIR IN THE PACKAGE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9956595 ↗
• MalfunctionJan 5, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND DRAIN WAS ATTACHED TO A RESERVOIR. IT WAS REPORTED THAT THE PATIENT CHANGED POSITION AND THE DRAIN WAS BROKEN. THE PATIENT'S DRAIN WAS REMOVED. ADDITIONAL INFORMATION IS HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7168887 ↗
• InjurySep 1, 2017Torn Material

  WHILE BEING REMOVED BY THE SURGEON, THE DRAIN TORE AND IT WAS ESTIMATED ABOUT 4-6CM PORTION WAS RETAINED IN THE CHEST.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6839185 ↗