BioGuard 00711784Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00816765013007), received between Oct 13, 2017 and Feb 13, 2019 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2019Structural Problem

  THE USER FACILITY REPORTED THE LID OF THE BIOPSY VALVE OPENED, WITH RESULTANT FLUID SPRAY FROM THE DEVICE DURING PROCEDURAL USE. THE FLUID DID NOT CONTACT THE USER, AND THERE WAS NO REPORT OF HARM TO THE PATIENT OR USER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8337355 ↗
• MalfunctionMay 10, 2018Fluid/Blood Leak

  THE USER FACILITY REPORTED FLUID SPRAY FROM THE BIOSHIELD BIOPSY VALVE. THE SPRAY DID NOT CONTACT THE USER, AND THERE WAS NO REPORT OF HARM TO THE PATIENT OR USER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7504004 ↗
• MalfunctionMay 9, 2018Fluid/Blood Leak; Self-Activation or Keying

  THE USER FACILITY REPORTED THE LID OF THE BIOSHIELD BIOPSY VALVE OPENED AND SPRAYED FLUID. THERE WAS NO REPORT OF HARM TO THE PATIENTS OR USERS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7500556 ↗
• MalfunctionDec 8, 2017Fluid/Blood Leak

  THE BIOSHIELD BIOPSY VALVE IS USED TO COVER THE OPENING TO THE BIOPSY/SUCTION CHANNEL INLET OF A GASTROINTESTINAL ENDOSCOPE. THE BIOSHIELD BIOPSY VALVE PROVIDES ACCESS FOR ENDOSCOPIC DEVICE PASSAGE AND EXCHANGE, HELPS MAINTAIN INSUFFLATION AND MINIMIZES LEAKAGE OF BIOMATERIAL FROM THE BIOPSY PORT THROUGHOUT THE GASTROINTESTINAL ENDOSCOPIC PROCEDURE. THE USER FACILITY REPORTED THAT POST PROCEDURE, THE BIOPSY VALVE IN THE BIOGUARD AIR/WATER AND SUCTION VALVE KIT SPRAYED FLUID. THERE WAS NO CONTACT WITH PATIENT OR USER.

  Patient problems: No Patient Involvement

  MAUDE report 7099659 ↗
• MalfunctionOct 27, 2017Detachment Of Device Component; Fluid/Blood Leak

  THE BIOPSY VALVE IS USED TO COVER THE OPENING TO THE BIOPSY/SUCTION CHANNEL INLET OF A GASTROINTESTINAL ENDOSCOPE. THE BIOPSY VALVE PROVIDES ACCESS FOR ENDOSCOPIC DEVICE PASSAGE AND EXCHANGE, HELPS MAINTAIN INSUFFLATION AND MINIMIZES LEAKAGE OF BIOMATERIAL FROM THE BIOPSY PORT THROUGHOUT THE GASTROINTESTINAL ENDOSCOPIC PROCEDURE. THE USER FACILITY REPORTED FOLLOWING A PROCEDURE THE LID OF THE BIOPSY VALVE OPENED AND SPRAYED FLUID. AS THE EVENT TOOK PLACE AFTER A PROCEDURE THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6983404 ↗
• MalfunctionOct 13, 2017Leak/Splash; Device Operates Differently Than Expected

  THE BIOSHIELD® BIOPSY VALVE IS USED TO COVER THE OPENING TO THE BIOPSY/SUCTION CHANNEL INLET OF A GASTROINTESTINAL ENDOSCOPE. THE BIOSHIELD® BIOPSY VALVE PROVIDES ACCESS FOR ENDOSCOPIC DEVICE PASSAGE AND EXCHANGE, HELPS MAINTAIN INSUFFLATION AND MINIMIZES LEAKAGE OF BIOMATERIAL FROM THE BIOPSY PORT THROUGHOUT THE GASTROINTESTINAL ENDOSCOPIC PROCEDURE. THE USER FACILITY REPORTED THE BIOPSY VALVE IN THE BIOGUARD AIR/WATER AND SUCTION VALVE KIT SPRAYED FLUID THAT CONTACTED A PHYSICIAN'S AND A NURSE'S PERSONAL PROTECTIVE EQUIPMENT. THERE IS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: Exposure to Body Fluids

  MAUDE report 6948829 ↗