Caresite® 470106Recalls & reported problems
B. Braun Medical Inc. · CARESITE® Needleless Connectors, 7" Bonded 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
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04046964093739), received between Jun 5, 2017 and Jun 19, 2020 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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 Leak7
- Contamination /Decontamination Problem1
Patient problems
- No Consequences Or Impact To Patient5
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 19, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THERE WAS SOMETHING LIKE LINT OR HAIR IN THE CONNECTOR SITE ATTACHED TO THE VALVE. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10175321 ↗MalfunctionApr 4, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS THAT THE TUBING IS COMING OUT OF THE CONNECTOR, NO FURTHER DETAILS. LIMITED INFORMATION PROVIDED. A PICTURE WAS PROVIDED WHICH INDICATES POTENTIAL BLOOD LEAKAGE. NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7396964 ↗MalfunctionApr 4, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS THAT THE TUBING IS COMING OUT OF THE CONNECTOR, NO FURTHER DETAILS. LIMITED INFORMATION PROVIDED. A PICTURE WAS PROVIDED WHICH INDICATES POTENTIAL BLOOD LEAKAGE. NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7396963 ↗MalfunctionApr 4, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS THAT THE TUBING IS COMING OUT OF THE CONNECTOR, NO FURTHER DETAILS. LIMITED INFORMATION PROVIDED. A PICTURE WAS PROVIDED WHICH INDICATES POTENTIAL BLOOD LEAKAGE. NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7396962 ↗MalfunctionOct 25, 2017Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 2: THERE WERE 2 INCIDENCES ON 2 DIFFERENT PATIENTS, BOTH INCIDENTS WERE INFUSING METHOTREXATE AND BICARB. DURING THE INFUSION, THE EXTENSION SET STARTED LEAKING. THE FIRST INCIDENT IS CAPTURED UNDER REPORT NUMBER 9614279-2017-00099. NO INJURIES REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6976457 ↗MalfunctionOct 25, 2017Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 1: THERE WERE 2 INCIDENCES ON 2 DIFFERENT PATIENTS, BOTH INCIDENTS WERE INFUSING METHOTREXATE AND BICARB. DURING THE INFUSION, THE EXTENSION SET STARTED LEAKING. THE SECOND INCIDENT IS CAPTURED UNDER REPORT NUMBER 9614279-2017-00100. NO INJURIES REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6976450 ↗MalfunctionAug 18, 2017Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: "I WAS GIVING THE CLONIDINE INFUSION NOTED AFTER FEW MINUTES THERE WAS A BACKFLOW OF BLOOD. WHILE FLUSHING THE BLOOD WITH SALINE, FLUID SPLASH ONTO MY FACE AND MOUTH NOT SURE IN MY EYES AS I WAS WEARING MY GLASSES." NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6805651 ↗MalfunctionJun 5, 2017Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: WHILE FLUSING THE Y-EXTENSION SET, IT BROKE CAUSING THE SET TO LEAK BLOOD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6610501 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
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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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