Duet® 46913 (UDI 00763000406004)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00763000406004), received between Apr 11, 2023 and Apr 4, 2024 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (10 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jan 22, 2024Open, Classified

   Potential for catheter disconnection from the patient line stopcock connectors.

   Z-1162-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT WHEN POURING THE DRAINAGE FLUID, THERE WAS LEAKAGE FOUND FROM THE SCREW PLUG OF THE DRAINAGE BAG. THE DOCTOR WAS NOTIFIED IMMEDIATELY TO CLAMP AND CLOSE THE DRAINAGE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19044715 ↗
• MalfunctionJan 9, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION, REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. USED FOR SUBARACHNOID HEMORRHAGE . IT WAS REPORTED, THAT THE PATIENT LINE BECAME LOOSE AND FREED ITSELF FROM THE STRAIN RELEASE AT THE LUERLOCK CONNECTOR, WHERE THE DEVICE CONNECTED TO THE PATIENT CATHETER CAUSING LEAKAGE. THE DEVICE WAS ORIGINALLY PLACED (B)(6) 2023. THE DEVICE WAS REPLACED ON (B)(6) 2024 AND AGAIN ON (B)(6) 2024. THE PATIENT'S STATUS WAS ALIVE-NO INJURY. ADDITIONAL INFORMATION: THE POINT OF DISCONNECTION HAS NOW BEEN CONFIRMED, (FOR ALL OCCURRENCES) AT THE PATIENT STOPCOCK DISTAL TO THE PATIENT. THE PATIENT LINE DISCONNECTS FROM THE HARD PLASTIC SLEEVE OF THE STOPCOCK. NURSES HAVE REPORTED, SEEING THE LINE 'JUST SLIP OUT'. THIS IS THIRD OCCURRENCE ON THIS PATIENT. THE DEVICE WAS REPLACED. AND THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18475705 ↗
• MalfunctionNov 30, 2023Disconnection; Disconnection

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT POST-OPERATIVELY, THE TUBING AT THE TEE BROKE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18238666 ↗
• MalfunctionNov 29, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE FLUID COLLECTION BAG LEAKED. IT WAS STATED THAT THE ADHESIVE WAS NOT ADHERING ENOUGH. AS A RESULT, THERE WAS RISK FOR INFECTION, HOWEVER, NO INFECTION OCCURRED. THE FLUID COLLECTION BAG WAS REPLACED. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE NO-INJURY. THE PATIENT'S MEDICAL HISTORY WAS INTRAVENTRICULAR HEMORRHAGE HYDROCEPHALUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18228666 ↗
• InjuryOct 23, 2023Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE.

  Patient problems: Cerebrospinal Fluid Leakage; Unspecified Infection

  MAUDE report 17984747 ↗
• MalfunctionOct 13, 2023Break; Disconnection; Fracture; Break; Disconnection; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THE PRODUCT FELL OFF AND WAS DAMAGED. IT WAS SUSPECTED THAT THE GLUE FELL OFF. THE PRODUCT WAS REPLACED WITH A NEW ONE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17932227 ↗
• MalfunctionSep 20, 2023Disconnection; Disconnection

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM USED FOR AN INTRACRANIAL INFECTION. IT WAS REPORTED THAT THE THREE WAY DISCONNECTED, AND THE ADHESIVE WAS NOT ADHERING ENOUGH. THE DEVICE WAS REPLACED. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17780524 ↗
• MalfunctionSep 18, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT AFTER THE EXTERNAL DRAINAGE SURGERY, IT WAS FOUND THAT THE GAUZE WRAPPED THE TEE JOINT WAS WET, AND THEN FOUND THAT THE TEE JOINT WAS DISCONNECTED. THE DEVICE WAS REPLACED WITH A NEW ONE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17764192 ↗
• MalfunctionJul 24, 2023Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING DEVICE. IT WAS REPORTED THAT AFTER SURGERY THERE WAS A LEAK AND IT WAS FOUND THAT THE WAY CONNECTION WAS DISCONNECTED. THE DEVICE WAS REPLACED WITH A NEW ONE AND THE ISSUE WAS RESOLVED. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17378675 ↗
• MalfunctionJul 20, 2023Fluid/Blood Leak; Mechanical Jam; Fluid/Blood Leak; Mechanical Jam

  MEDTRONIC RECEIVED INFORMATION REGARDING A EXTERNAL DRAINAGE SYSTEM. IT WAS REPORTED THAT THE TEE (JOINT) WAS DISCONNECTED. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. NO IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17361954 ↗
• MalfunctionJul 19, 2023Disconnection; Disconnection

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING DEVICE. IT WAS REPORTED THAT AFTER CONNECTING THE DEVICE, IT WAS DEGUMMED, AND DISCONNECTED AT THE T JOINT. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE.THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17353501 ↗
• MalfunctionJul 18, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING DEVICE. IT WAS REPORTED THAT AFTER EXTERNALLY DRAINAGE SURGERY THE BAG WAS FOUND TO BE LEAKING. THE SITE PLACED A NEW ONE AND THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17345844 ↗
• MalfunctionApr 12, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A DUET DRAINAGE BURETTE AND BAGS. IT WAS REPORTED THAT A COUPLE DAYS POST INSERTION THE DEVICE HAD A LEAK FROM THE CONNECTION OF THE CATHETER TO THE DRAINAGE BURETTE. THERE WAS NO INTERVENTION PERFORMED AND NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16725492 ↗
• MalfunctionApr 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A DUET DRAINAGE BURETTE AND BAGS. IT WAS REPORTED THAT A COUPLE DAYS POST INSERTION THE DEVICE HAD A LEAK AT THE 3 WAY TAP INTO THE DRAINAGE BAG. THERE WAS NO INTERVENTION PERFORMED AND NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16716244 ↗