BD PureHub 306597Recalls & reported problems
Becton, Dickinson And Company · CAP DISINFECTION STRIP US · Class 2
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 00382903065974), received between Oct 31, 2019 and Oct 31, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 31, 2019Leak/Splash; Leak/Splash
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PURE HUB DISINFECTING CAP STRIPS EXPERIENCED LEAKAGE WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 306597, BATCH NO: UNKNOWN. EVENT DESCRIPTION: IT WAS REPORTED THAT THE ACCOUNT HAS HAD ADDITIONAL LEAKAGES OF BD MAXZERO. IN SPEAKING WITH THE ACCOUNT, THEY FEEL THAT THESE ISSUES OCCURRED AFTER THEY STARTED USING BD PUREHUB AS THEY HAVE BEEN USING BD MAXZERO FOR YEARS AND HAVE NEVER HAD ANY ISSUES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9260404 ↗
Other Cap, device disinfectant devices
- SwabSleeve™ SCXT3-5-2000Icu Medical, Inc. · Cap, device disinfectant1 recall0 reports
- BD PureHub 306596Becton, Dickinson And Company · Cap, device disinfectant2 reports
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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