B.BRAUN 354250Recalls & reported problems
B. Braun Medical Inc. · CARESITE® Positive Displacement Needleless Connectors, 8" Bonded High Pressure Bifurcated Small Bore Extension Set · 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 04046955194827), received between May 18, 2022 and Sep 4, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (2 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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash2
- Detachment of Device or Device Component1
Patient problems
- Chemical Exposure1
- Hemorrhage/Blood Loss/Bleeding1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 4, 2026Leak/Splash; Detachment of Device or Device Component
Patient problems: Chemical Exposure; Hemorrhage/Blood Loss/Bleeding
MAUDE report 50611624 ↗MalfunctionMay 18, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: AN EXPERIENCED ONCOLOGY NURSE ATTACHED THE TUBING FOR A 5-FU BOLUS. THE INFUSION INFUSED FOR A FEW MINUTES BEFORE THE PATIENT HEARD A POP AND THE CHEMO LEAKED ONTO HER BLANKET AND THE PATIENT'S BLOUSE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14427204 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 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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