Caresite® 470124Recalls & reported problems
B. Braun Medical Inc. · CARESITE® Needleless Connector, 8" Bonded High Pressure Small Bore Extension Set · Class 2
All models of Caresite (23)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046964298738), received between Jan 20, 2017 and Dec 16, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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.
Most reported problems
Device problems
- Fluid/Blood Leak3
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 16, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: "THE SPIN LOCK CONNECTOR IS DIFFICULT TO ATTACH TO THE IV CATHETER. THE SHAPE APPEARS DIFFERENT THAN THE PRIOR VERSION OF THE SET WITH THE BLUE CLAMP, CAUSING LEAKAGE OF BLOOD AND FLUID OUT OF THE IV CATHETER DUE TO MISCONNECTIONS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11019755 ↗MalfunctionNov 5, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: WHEN THE CLINICIAN WAS DRAWING BLOOD FROM A PATIENT USING A VACCUTAINER TO THE CARESITE VALVE, UPON DISCONNECTING THE VACUTAINER FROM THE CARESITE VALVE, A SCANT OR DROP AMOUNT OF BLOOD LEAKED FROM THE CARESITE VALVE. NO INJURIES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8037420 ↗MalfunctionJan 20, 2017Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY USER FACILITY: SET FELL APART WHILE PRIMING BLOOD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6267445 ↗
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- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- 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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