BLAKE 2228Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705031003569), received between Feb 6, 2020 and Apr 24, 2024 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND A DRAIN WAS USED. "MCT BUBBLING, NOT DRAINING, REMOVED AND HOLE IN TUBING FOUND ". NO OTHER DETAILS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 19176966 ↗
• MalfunctionAug 25, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED A PATIENT UNDERWENT "AN" UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A DRAIN WAS USED. RIGHT CHEST TUBE HAD HOLE TORN IN IT. PRESUMED FROM FREQUENT STRIPPING DUE TO LARGE CLOTS IN LINE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17625677 ↗
• InjuryMay 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A RADICAL VULVECTOMY ON AN UNKNOWN DATE AND A DRAIN WAS USED. PATIENT DEVELOPED INFECTION AT THE GROIN DRAIN SITE. ANTIBIOTICS GIVEN. RESULTS OF CULTURE: PENDING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 16930481 ↗
• InjuryMay 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A HEMIVULVECTOMY ON AN UNKNOWN DATE AND A DRAIN WAS USED. PATIENT DEVELOPED INFECTION AT THE GROIN DRAIN SITE. ANTIBIOTICS GIVEN. RESULTS OF CULTURE: KLEBSIELLA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 16930451 ↗
• InjuryMay 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A HEMIVULVECTOMY ON AN UNKNOWN DATE AND A DRAIN WAS USED. PATIENT DEVELOPED INFECTION AT THE GROIN DRAIN SITE. ANTIBIOTICS GIVEN. RESULTS OF CULTURE: DELFTIA ACIDOVARANS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 16924398 ↗
• MalfunctionFeb 10, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A DRAIN PRODUCT RECEIVED WAS NOTED TO INCLUDE PRODUCT LABELING TO HAVE AN INCORRECT WARNING LABEL CONCERNING THE PRESENCE OF LATEX IN THE DRAIN. THE LABELING CONTAINS A WARNING STATING IT CONTAINS LATEX WHEN, IN FACT, IT DOES NOT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9687137 ↗
• MalfunctionFeb 6, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A DRAIN PRODUCT RECEIVED WAS NOTED TO INCLUDE PRODUCT LABELING TO HAVE AN INCORRECT WARNING LABEL CONCERNING THE PRESENCE OF LATEX IN THE DRAIN. THE LABELING CONTAINS A WARNING STATING IT CONTAINS LATEX WHEN, IN FACT, IT DOES NOT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9676174 ↗