SITE-SCRUB 3882100Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10801741086943), received between Jul 18, 2019 and Mar 24, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Defective Component” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026Product Quality Problem

  IT WAS REPORTED OPENED UP A SITE SCRUB AND IT WAS COMPLETELY DRY, WHEREAS IT IS SUPPOSED TO BE WET FROM THE CLEANING SOLUTION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24676901 ↗
• MalfunctionJan 26, 2026Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED BY THE CUSTOMER THAT THE PRODUCT IS DAMAGED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24184436 ↗
• MalfunctionMar 19, 2025Defective Component; Defective Component

  IT WAS REPORTED SCRUB SITES WERE DRY OR ALMOST DRY AND UNUSABLE. THE ISSUE WAS DISCOVERED DURING USE IN A DIALYSIS TREATMENT INVOLVING DIRECT PATIENT CARE. NO MEDICAL TREATMENT REQUIRED ¿ MEDICAL STAFF HAD TO GET REPLACEMENTS DUE TO THE DELAY. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED; THIS OCCURRED WITH THREE DEVICES. THIS REPORT ADDRESSES ALL THREE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21646271 ↗
• MalfunctionMar 19, 2025Defective Component; Defective Component

  IT WAS REPORTED SCRUB SITES WERE DRY OR ALMOST DRY AND UNUSABLE. THE ISSUE WAS DISCOVERED DURING USE IN A DIALYSIS TREATMENT INVOLVING DIRECT PATIENT CARE. NO MEDICAL TREATMENT REQUIRED ¿ MEDICAL STAFF HAD TO GET REPLACEMENTS DUE TO THE DELAY. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES BOTH DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21646267 ↗
• MalfunctionMar 19, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT SCRUB SITES WERE DRY OR ALMOST DRY AND UNUSABLE. THE ISSUE WAS DISCOVERED DURING USE IN A DIALYSIS TREATMENT INVOLVING DIRECT PATIENT CARE. NO MEDICAL TREATMENT REQUIRED ¿ MEDICAL STAFF HAD TO GET REPLACEMENTS DUE TO THE DELAY. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES BOTH DEVICES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21644266 ↗
• MalfunctionSep 12, 2024Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT THERE IS INCREASE IN FAILING MEMBRANES ON THEIR TEGO CONNECTORS. THE CUSTOMER USES TEGO NEEDLESS CONNECTORS ON ALL HEMODIALYSIS LINES. THEY STARTED USING SAFESCRUB AND SITESCRUB IN A TRIAL AND HAVE NOTICED AN INCREASE IN FAILING MEMBRANES ON THEIR TEGO CONNECTORS. THEY BELIEVE ITS ATTRIBUTED TO THE "VIGOROUS" SCRUBBING OF THE BD DISINFECTANT CAPS. FOLLOW UP RESPONSE RECEIVED O 19/08/2024 IT¿S HAPPENING AT RANDOM ON A FEW DIFFERENT OCCASIONS AND ACROSS SEVERAL LOT NUMBERS. THE EVENT WAS DURING PATIENT USE. THERE WAS NO PATIENT INJURY BUT THE NURSES HAD TO CHANGE THEIR TEGO CONNECTORS OUT WHICH WAS AN ADDITIONAL WORKLOAD TO THEM. THE BD PRODUCT IS NOT DAMAGED. THE DAMAGE WAS TO THE TEGO NEEDLESS CONNECTOR. THE CUSTOMER BELIEVES OUR SCRUB CAP CAUSED DAMAGE TO THE MEMBRANE DUE TO THE FOAM FINGERS AND ¿VIGOROUS¿ SCRUB OF THE DEVICE. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20200814 ↗
• MalfunctionOct 7, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT THE SITESCRUB "FOAM FINGER" BROKE OFF AND DISLODGED IN THE DIALYSIS CATHETER. CATHETER WAS REMOVED AND A NEW DEVICE WAS PLACED. NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9161883 ↗
• MalfunctionJul 18, 2019Defective Component

  IT WAS REPORTED THAT THE SITE-SCRUB WAS DRY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8802364 ↗