SITE-SCRUB 3882025Recalls & reported problems
Bard Access Systems, Inc. · Site-ScrubTM IPA Device · Class U
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10801741086936), received between Nov 29, 2017 and Jul 14, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment Of Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment Of Device Component1
- Material Integrity Problem1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 14, 2026Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT DEVICE WAS DAMAGED. NO FURTHER DETAILS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25820870 ↗MalfunctionNov 29, 2017Detachment Of Device Component; Material Integrity Problem
THE FACILITY REPORTED TO THE SALES REP THAT DURING A CLABSI ERADICATION TRAINING, THE FOAM FINGERS DETACHED FROM THE SITESCRUB. IT WAS STATED THAT WHEN USED ON THE OPEN HUB OF A 3FRENCH POWER PICC, IT LEFT FIBERS AND BITS OF FOAM ON THE HUB. THIS WAS NOT USED ON A PATIENT AS IT WAS DURING TRAINING.
Patient problems: No Patient Involvement
MAUDE report 7068450 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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