BioShield 00711126 (UDI 00816765011058)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816765011058), received between Aug 24, 2017 and Aug 24, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2017Fluid/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 DURING A PROCEDURE THE LID OF THE BIOPSY VALVE OPENED AND SPRAYED A NURSE WITH BODILY FLUID. THE NURSE WAS WEARING PROPER PERSONAL PROTECTIVE EQUIPMENT HOWEVER THE FLUID CAME IN CONTACT WITH HER SKIN. THE NURSE WASHED THE AFFECTED SKIN AND NO FURTHER TREATMENT WAS SOUGHT. THERE WAS NO REPORT OF HARM TO THE PATIENT.

  Patient problems: Exposure to Body Fluids

  MAUDE report 6817396 ↗