Site-Rite 9000096Recalls & reported problems
Bard Access Systems, Inc. · 96"Probe Cover (US)10pk · Class 2
All models of Site-Rite (20)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741037764), received between Sep 26, 2023 and Sep 26, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective 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.
Most reported problems
Device problems
- Defective Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 26, 2023Defective Component; Defective Component
IT WAS REPORTED BY THE CUSTOMER "58 Y/F (YEAR OLD FEMALE) BOARDED FOR RIGHT BREAST MAG SEED LOCALIZED LUMPECTOMY AND AT THE END OF THE CASE, THERE WAS BLOOD NOTED ON THE SCOPE. NO VISIBLE SIGNS OF COMPROMISED INTEGRITY ON THE DRAPE SO THE NURSE FILLED THE COVER WITH WATER AND NOTICED MULTIPLE PIN HOLES ON THE DRAPE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17819613 ↗
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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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