BD PureHub 306596Recalls & reported problems
Becton, Dickinson And Company · CAP DISINFECTION SINGLES US · Class 2
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 30382903065968), received between Dec 5, 2018 and Feb 11, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Material Integrity Problem1
- Material Separation1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 11, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21360733 ↗MalfunctionDec 5, 2018Material Separation; Material Integrity Problem; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING USE OF THE BD PUREHUB¿ DISINFECTING CAP THAT SPONGE SEPARATED FROM CAP AND STAYED STUCK TO THE HUB. IT WAS ALSO REPORTED THAT THERE WAS ECESSIVE ALCOHOL IN SPONGE THAT DRIPPED DOWN PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8134046 ↗
Other Cap, device disinfectant devices
- SwabSleeve™ SCXT3-5-2000Icu Medical, Inc. · Cap, device disinfectant1 recall0 reports
- BD PureHub 306597Becton, Dickinson And Company · Cap, device disinfectant1 report
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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