BLAKE 2214Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705031003507), received between Oct 28, 2019 and Aug 23, 2024 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 23, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE ON AN UNKNOWN DATE IN (B)(6)2024 AND A DRAIN WAS USED. POST OP, THE DRAIN CAME APART AT THE Y JUNCTION PREMATURELY. PATIENT NEEDED TO BE RETURNED TO THE OR TO REMOVE THE DRAIN. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20047913 ↗
• InjuryAug 23, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE ON AN UNKNOWN DATE IN 2024 AND A DRAIN WAS USED. POST OP, THE DRAIN CAME APART AT THE Y JUNCTION PREMATURELY. PATIENT NEEDED TO BE RETURNED TO THE OR TO REMOVE THE DRAIN. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20046833 ↗
• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE ON AN UNKNOWN DATE IN 2024 AND A DRAIN WAS USED. POST OP, THE DRAIN CAME APART AT THE Y JUNCTION PREMATURELY. PATIENT NEEDED TO BE RETURNED TO THE OR TO REMOVE THE DRAIN. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20041998 ↗
• InjuryAug 22, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE ON (B)(6) 2024 AND A DRAIN WAS USED. POST OP, THE DRAIN CAME APART AT THE Y JUNCTION PREMATURELY. PATIENT NEEDED TO BE RETURNED TO THE OR TO REMOVE THE DRAIN. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20040479 ↗
• InjuryJul 30, 2024

  THE NEUROSURGEON WAS AT BEDSIDE TO REMOVE A BULB SUCTION DRAIN (BLAKE DRAIN) FROM A ONE-DAY POST-SURGICAL PATIENT. THE PATIENT HAD A L5-S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION AND RIGHT L4-5 LAMINOTOMY/FORAMINOTOMY WITH INTRAPROCEDURAL DRAIN PLACEMENT ON (B)(6) 2024 AND WAS BEING PREPARED FOR DISCHARGE. UPON REMOVING THE SUTURES OF THE DRAIN AND GENTLY PULLING ON THE DEVICE, THE DRAIN "CAME APART, LEAVING A PORTION OF THE DRAIN INSIDE THE PATIENT" NEAR THE POINT OF ENTRY. THE NEUROSURGEON ATTEMPTED TO REMOVE THE DRAIN FRAGMENT FROM THE PATIENT BUT WAS UNSUCCESSFUL. THE PATIENT REQUIRES RETURN TO THE OPERATING ROOM FOR SURGICAL REMOVAL OF MEDICAL DEVICE. THE PATIENT HAD NOT BEEN NPO AND THEREFORE WAS REQUIRED TO STAY IN THE HOSPITAL FOR AN ADDITIONAL DAY TO SAFELY COMPLETE INTERVENTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 19877196 ↗
• InjuryJul 30, 2024

  THE PATIENT WAS ONE DAY POSTOPERATIVE L3-4, L4-5 LAMINECTOMY AND WAS BEING PREPARED FOR DISCHARGE. THE NEUROSURGICAL PHYSICIAN ASSISTANT WAS AT BEDSIDE TO REMOVE BULB SUCTION DRAIN (BLAKE DRAIN) THAT HAD BEEN PLACED INTRAOPERATIVELY. WHILE REMOVING BLAKE DRAIN, THE DRAIN TUBING BROKE NEAR THE POINT OF ENTRY WITH A PORTION OF THE DRAIN REMAINING WITHIN THE INCISION. THE NEUROSURGEON WAS IMMEDIATELY NOTIFIED AND ARRIVED AT BEDSIDE BUT WAS UNABLE TO RETRIEVE THE DRAIN FRAGMENT. THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR SAFE RETRIEVAL OF RETAINED MEDICAL DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 19876898 ↗
• MalfunctionDec 1, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND A DRAIN WAS USED. CATHETER SEPARATED WITHIN PATIENT AND HAD TO BE REMOVED DURING PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18245320 ↗
• InjuryNov 30, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND A DRAIN WAS USED. THE DRAIN SEPARATED AND DISLODGED IN THE PATIENT. PATIENT HAD TO GO TO THE CATH LAB TO HAVE THE DISLODGED END OF THE CATHETER REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18236058 ↗
• InjuryOct 28, 2019Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND A DRAIN WAS USED. ON (B)(6) 2019 THEY WENT TO REMOVE THE DRAIN BEDSIDE AND IT SNAPPED OFF. THE DRAIN WAS SURGICALLY REMOVED ON (B)(6) 2019. A NEW DRAIN WAS NOT NEEDED. THE PATIENT WAS DISCHARGED ON (B)(6) 2019. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient; No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9246804 ↗