BLAKE 2229Recalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 10705031003576), received between Nov 21, 2017 and Jul 30, 2026 — classified as 21 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (20 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 76 reports, in the reporter's own words as published by the FDA.

• 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 (b)(6) post surgery, The patient was cleaning the outside of the drain, by wiping it down the length and the end snapped off. It snapped off nearer to the wound. Drain was discarded and replaced with other. A sample is available, not original. Additional information has been requested.

  Patient problems: Insufficient Information

  MAUDE report 50089957 ↗
• MalfunctionMar 9, 2026Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE A DRAIN WAS USED. IT WAS FOUND BEFORE USE THAT THE TROCAR NEEDLE AND THE DRAIN HAD BEEN ADHERED. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED. UPON RECEIPT AND ANALYSIS, STICKING MARKS ON THE TROCAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24545284 ↗
• MalfunctionMar 9, 2026Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE A DRAIN WAS USED. IT WAS FOUND BEFORE USE THAT THE TROCAR NEEDLE AND THE DRAIN HAD BEEN ADHERED. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED.UPON RECEIPT AND ANALYSIS, STICKING MARKS ON THE TROCAR, NEARBY DRAIN-TROCAR JOINT WAS VISIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24545187 ↗
• MalfunctionMar 6, 2026Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 202 AND DRAIN WAS USED. WHEN OPENING THE PACKAGE, IT WAS FOUND THAT THE TROCAR NEEDLE AND THE DRAIN HAD BEEN ADHERED. THE PRODUCT WAS NOT USED FOR THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. UPON RECEIPT AND ANALYSIS, STICKING MARKS WERE FOUND ON THE TROCAR AND A CHIP-OFF MARKS ON DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24532614 ↗
• MalfunctionFeb 26, 2026Break

  IT WAS REPORTED A PATIENT UNDERWENT AN RADICAL ROBOT-ASSISTED PROSTATECTOMY PROCEDURE ON (B)(6) 2026 AND A DRAIN WAS USED. THIS PRODUCT WAS INSERTED DURING. IN THE WARDS/ICU AND MANAGED UNDER NEGATIVE PRESSURE. ON (B)(6), THE ASSIGNED NURSE NOTICED THAT NEGATIVE PRESSURE WAS NOT BEING MAINTAINED AND CHECKED THE LINE, THEY FOUND A CRACK NEAR THE AREA WHERE THE FIXATION SUTURE WAS PLACED AND WAS REPORTED TO THE DOCTOR. THE DRAIN WAS REMOVED AFTER THAT. 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 24459774 ↗
• MalfunctionDec 22, 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. DURING THE PROCEDURE, IT WAS FOUND THAT THERE HAD BEEN A FOREIGN MATTER INSIDE THE DRAIN, ABOUT 7 CM FROM THE BASE OF THE TROCAR NEEDLE. THE PRODUCT WAS IN THE STERILE PACKAGE. THE PRODUCT WAS NOT USED FOR THE PATIENT. 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 23862398 ↗
• MalfunctionNov 26, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A DRAIN WAS USED. POST-OP, THE DRAIN WAS FOUND WITH A DAMAGED PART AT THE TUBING SITE. LEAKAGE WAS FOUND. THE NURSE USED PLASTIC TAPE TO WRAP AROUND THE TUBING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23658738 ↗
• MalfunctionAug 28, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2025 AND A DRAIN WAS USED. THE DRAIN HAD ADHERED TO THE TROCAR NEEDLE. A HOLE WAS CREATED ON THE DRAIN WHEN SEPARATED THEM. THIS EVENT WAS FOUND BEFORE USE. 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 EVALUATION THE DRAIN HAD FINE STICKING MARKS VISIBLE ON TROCAR AND CHIP-OFF MARKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22915955 ↗
• MalfunctionAug 22, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN BREAST AND ENDOCRINE SURGERY ON AND UNKNOWN DATE AND A DRAIN WAS USED. THE DRAIN HAD ADHERED TO THE TROCAR NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THIS EVENT WAS FOUND BEFORE USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. UPON RECEIPT AND EVALUATION IT WAS OBSERVED DRAIN HAD A THREE CHIP-OFF MARKS ON UPPER SURFACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22878976 ↗
• MalfunctionAug 22, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN BREAST AND ENDOCRINE SURGERY ON AN UNKNOWN DATE AND A DRAIN WAS USED. THE DRAIN HAD ADHERED TO THE TROCAR NEEDLE WHEN TRIED TO USE THE PRODUCT IN THE SURGICAL FIELD. THE DRAIN AND THE TROCAR NEEDLE WERE SEPARATED LITTLE BY LITTLE BUT THERE WAS A POSSIBILITY OF DAMAGE, SO ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THIS EVENT WAS FOUND BEFORE USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. UPON RECEIPT AND EVALUATION IT WAS OBSERVED DRAIN HAD FINE STICKING MARKS VISIBLE ON TROCAR, HAD A CHIP-OFF MARK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22878740 ↗
• MalfunctionAug 22, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PLASTIC SURGERY ON AN UNKNOWN DATE IN 2025 AND A DRAIN WAS USED. THE DRAIN HAD ADHERED TO THE TROCAR NEEDLE WHEN THE PRODUCT WAS OPENED AND TAKEN OUT IN THE OPERATION ROOM AND USE WAS STOPPED. 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 22871685 ↗
• MalfunctionAug 21, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6) 2025 AND A DRAIN WAS 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 THE DRAIN HAD A CHIP-OFF MARK ON UPPER SURFACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22867003 ↗
• MalfunctionAug 18, 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 FROM THE BEGINNING. THERE WAS A POSSIBILITY THAT THE DRAIN WAS DAMAGED SO 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 ANALYSIS THE DRAIN HAD CHIP-OFF MARKS ON UPPER SURFACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22829421 ↗
• MalfunctionAug 18, 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 FROM THE BEGINNING. THERE WAS A POSSIBILITY THAT THE DRAIN WAS DAMAGED SO 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 ANALYSIS THE DRAIN HAD CHIP-OFF MARKS ON UPPER SURFACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22829404 ↗
• MalfunctionAug 1, 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. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED. UPON RECEIPT AND ANALYSIS, OBSERVED STICKING MARKS ON TROCAR WERE VISIBLE, ALSO THE DRAIN HAD CHIP-OFF MARKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22688772 ↗
• MalfunctionJul 21, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2025 AND A DRAIN WAS USED. THE DRAIN HAD ADHERED TO THE TROCAR NEEDLE. THE NURSE DECIDED THAT USE WAS STOPPED. A SILICONE PART OF THE DRAIN HAD ADHERED TO THE TROCAR NEEDLE WHEN SEPARATED THEM. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22555108 ↗
• InjuryJul 18, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN ABDOMINAL HYSTERECTOMY ON (B)(6) 2025 AND A DRAIN WAS USED. 15FR WAS PLACED IN THE DOUGLAS POUCH AFTER AN OB-GYN SURGERY. THE DOCTOR TRIED TO REMOVE IT BUT IT COULD NOT REMOVE BECAUSE THE RESERVOIR COULD NOT SUCK EXUDATE PROPERLY ON THE FIRST DAY AFTER SURGERY AND ANOTHER DOCTOR TRIED TO REMOVE IT BUT THE TUBE WAS BROKEN AND THE STUMP PART GOT INTO THE ABDOMEN, AND RE-OPERATION WAS PERFORMED TO REMOVE THE FOREIGN MATTER FROM THE ABDOMEN. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22546123 ↗
• MalfunctionJul 18, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED A PATIENT UNDERWENT A NEPHRECTOMY ON (B)(6) 2025 AND A DRAIN WAS USED. AT THE TIME OF PLACING THE DRAIN, ALREADY IN THE CLOSING OF THE PATIENT, IT WAS SEEN THAT THE NEGATIVE PRESSURE COULD NOT BE MADE. THEY CHECKED THE DRAIN, OBSERVING A HOLE, PUT A TEGADERM ON IT AND ACHIEVED THE FUNCTIONAL GOAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22542225 ↗
• InjuryJul 15, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2025 AND A DRAIN WAS USED. THE DRAIN BROKE A PORTION LEFT CONFIRMED VIA XRAY. COMPLETED BY REOPERATION. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22511295 ↗
• InjuryJul 1, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A DRAIN WAS USED. THE DRAIN MALFUNCTIONED SEVERELY IT HAS RESISTANCE ON REMOVAL, BREAKS EASILY AND PATIENT HAD RETENTION OF DRAIN TUBING REQUIRING A VISIT AND OTHER ISSUES. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22376372 ↗
• InjuryJul 1, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A DRAIN WAS USED. THE DRAIN MALFUNCTIONED SEVERELY IT HAS RESISTANCE ON REMOVAL, BREAKS EASILY AND PATIENT HAD RETENTION OF DRAIN TUBING REQUIRING A VISIT AND OTHER ISSUES. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22376360 ↗
• MalfunctionJun 10, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN OPEN SURGERY O (B)(6) 2025 AND A DRAIN WAS USED. THERE HAD BEEN A HOLE ON THE DRAIN. 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 EVALUATION, THE HOLE WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22178513 ↗
• MalfunctionMay 5, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2025 AND A DRAIN WAS USED. THE DRAIN WAS ADHERED TO THE STERILIZATION PACKAGE IN WHICH IT WAS PACKED. AFTER PEELING THEM OFF, WHEN WATER WAS PASSED THROUGH THE DRAIN, WATER LEAKED FROM THE MIDDLE OF THE DRAIN. 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 PRESENT ON THE TROCAR, NEARBY DRAIN-TROCAR JOINT. AND CHIP-OFF MARKS ON UPPER SURFACE OF THE DRAIN WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21959299 ↗
• MalfunctionMay 5, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21959298 ↗
• MalfunctionApr 25, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATED AND TOPICAL SKIN ADHESIVE WAS USED. THERE WAS A CRACK 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 21911400 ↗