BLAKE 2231Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705031003590), received between Apr 12, 2018 and Nov 26, 2024 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionNov 26, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED A PATIENT UNDERWENT A RADICAL MASTECTOMY PROCEDURE ON (B)(6) 2024 AND A DRAIN WAS USED. DURING PROCEDURE, THAT WHEN THE STERILE PACKAGE WAS OPENED IN THE OR A HAIR WAS VISIBLE AND EMBEDDED IN THE PACKAGING. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. DEVICE RETURNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20785178 ↗
• InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TITLE: THE PREVENTIVE EFFECTS OF PERIOPERATIVE ORAL CARE ON SURGICAL SITE INFECTIONS AFTER PANCREATIC CANCER SURGERY: A RETROSPECTIVE STUDY. THE AIM OF THIS STUDY WAS TO INVESTIGATE THE PREVENTIVE EFFECTS OF PERIOPERATIVE ORAL CARE ON THE INCIDENCE OF SURGICAL SITE INFECTIONS AFTER PANCREATIC CANCER SURGERY. BETWEEN FEBRUARY 1, 2011, AND DECEMBER 31, 2018, 103 PATIENTS WITH PANCREATIC DUCTAL ADENOCARCINOMA WHO UNDERWENT PANCREATIC CANCER SURGERY WITH CURATIVE INTENT WERE INCLUDED IN THE STUDY. 75 PATIENTS RECEIVED PERIOPERATIVE ORAL CARE BY DENTISTS AND DENTAL HYGIENISTS (ORAL CARE GROUP), WHEREAS 28 DID NOT (CONTROL GROUP). IN THE ORAL CARE GROUP, THERE WERE 41 MALES AND 34 FEMALES WITH A MEAN AGE OF 70.4 +/-8.7 YEARS AND A MEAN BMI OF 22.3+/-3.2 KG/M2. IN THE CONTROL GROUP, THERE WERE 16 MALES AND 12 FEMALES WITH A MEAN AGE OF 64.6+/-10.0 YEARS AND A MEAN BMI OF 23.0+/-3.3 KG/M2. SURGICAL PROCEDURES THAT WERE PERFORMED INCLUDED PANCREATICODUODENECTOMY, DISTAL PANCREATECTOMY, AND STANDARD LYMPHADENECTOMY. BEFORE CLOSING THE SURGICAL INCISION, THE SURGEON REPLACED THEIR GLOVES, AND THE ABDOMINAL CAVITY WAS FLUSHED WITH 10 L OF SALINE SOLUTION. ABDOMINAL DRAINS (BLAKE DRAINS®,19 FR,

  Patient problems: Unspecified Infection

  MAUDE report 15114056 ↗
• InjuryApr 26, 2021Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A HERNIA REPAIR ON (B)(6) 2021 AND A DRAIN WAS USED. WHEN THE DRAIN WAS REMOVED, IT BROKE AND PART OF IT REMAINED IN THE ABDOMEN. TO REMOVE THE PIECE THE PATIENT WAS RE-OPERATED ON. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11723973 ↗
• InjuryApr 26, 2021Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A BILE DUCT PROCEDURE ON (B)(6) 2021 AND A DRAIN WAS USED. WHEN THE DRAIN WAS REMOVED, IT BROKE AND PART OF IT REMAINED IN THE ABDOMEN. THE PATIENT WAS RE-OPERATED TO REMOVE THE PIECE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11723409 ↗
• InjuryApr 14, 2021Break; Break

  IT WAS REPORTED A RECIPIENT PATIENT UNDERWENT RENAL TRANSPLANT ON AN UNKNOWN DATE AND A DRAIN WAS USED. DURING DRAIN REMOVAL ON (B)(6) 2021, THE DRAIN BROKE AND WAS LEFT IN THE PATIENT'S ABDOMEN (21CM). DEVICE BROKE AND WAS PARTIALLY LEFT WITHIN THE PATIENT. EMERGENCY OPERATION WAS DONE TO REMOVE THE DRAIN IN EMERGENCY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11668276 ↗
• InjuryApr 16, 2019Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2018 AND A DRAIN WAS USED. MULTIPLE ATTEMPTS TO REMOVE RECTUS SHEATH CATHETER (POST SURGERY TWO DAYS PRIOR) HOWEVER THIS RESULTED IN THE CATHETER BREAKING LEADING TO A FOREIGN BODY BEING LEFT IN PATIENT'S LOWER ABDOMEN. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8519916 ↗
• InjuryApr 12, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE AND DRAIN WAS USED. THE DRAIN WAS REMOVED POSTOPERATIVELY BY AN CAREGIVER ON (B)(6) 2017. CT IMAGES WERE MADE ON (B)(6) 2017. THE CT IMAGES SHOWED THAT A PART OF THE DRAIN WAS LEFT IN THE ABDOMEN OF THE PATIENT. RE-OPERATION FOR THE REMOVAL OF THE DRAIN WAS NECESSARY, THIS WAS CARRIED OUT ON (B)(6) 2017.

  Patient problems: Foreign Body In Patient; Not Applicable

  MAUDE report 7425381 ↗