Caresite® 470107Recalls & reported problems
B. Braun Medical Inc. · CARESITE® Needleless Connectors, 7" Bifurcated 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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04046964183911), received between Nov 7, 2018 and Dec 5, 2020 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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 Leak5
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
- Chemical Exposure1
- Missed Dose1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 5, 2020Fluid/Blood Leak; Fluid/Blood Leak
EVENT 2: AS REPORTED BY THE USER FACILITY: THE PRODUCT WAS ASSEMBLED BY ANESTHESIOLOGIST IN THE OPERATING ROOM. UPON ARRIVAL IN THE RECOVERY ROOM, THE PATIENT'S UNDERPAD WAS WET AND SOILED WITH BLOOD. THE CLINICIAN IRRIGATED THE EXTENSION SET AND THE PRESENCE OF A HOLE IN THE GREEN PART BEFORE THE NEEDLELESS CONNECTOR WAS IDENTIFIED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10950559 ↗MalfunctionDec 5, 2020Fluid/Blood Leak; Fluid/Blood Leak
EVENT 1: AS REPORTED BY THE USER FACILITY: THE PRODUCT WAS ASSEMBLED BY ANESTHESIOLOGIST IN THE OPERATING ROOM. UPON ARRIVAL IN THE RECOVERY ROOM, THE PATIENT'S UNDERPAD WAS WET AND SOILED WITH BLOOD. THE CLINICIAN IRRIGATED THE EXTENSION SET AND THE PRESENCE OF A HOLE IN THE GREEN PART BEFORE THE NEEDLELESS CONNECTOR WAS IDENTIFIED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10950496 ↗MalfunctionAug 12, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT A CRACK WAS OBSERVED ON THE GREEN PORTION OF THE Y-EXTENSION SET. CHEMOTHERAPY OF CYCLOPHOSPHAMIDE AND BLOOD LEAKED. NO INJURY REPORTED.
Patient problems: Chemical Exposure; Missed Dose
MAUDE report 10397399 ↗MalfunctionNov 7, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 2: DURING ADMINISTRATION, THE EXTENSION SET LEAKED CHEMOTHERAPY. LEAKAGE OCCURRED AT THE PRIMARY SET CONNECTION AND AT THE LEUR LOCK CONNECTION ON THE Y-SITE. NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8047910 ↗MalfunctionNov 7, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 1: DURING ADMINISTRATION, THE EXTENSION SET LEAKED CHEMOTHERAPY. LEAKAGE OCCURRED AT THE PRIMARY SET CONNECTION AND AT THE LEUR LOCK CONNECTION ON THE Y-SITE. NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8047901 ↗
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page