Caresite® 470117Recalls & reported problems
B. Braun Medical Inc. · 1.2 Micron Filtered Extension Set with CARESITE® Injection Site · Class 2
All models of Caresite (23)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04046964183997), received between Nov 8, 2019 and Nov 3, 2020 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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 Leak4
- Contamination /Decontamination Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Known Impact Or Consequence To Patient2
- Venipuncture1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 3, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: "THE TREATING NURSE ATTACHED THE BAG TO THE PATIENT AND DRUG [PACLITAXEL] STARTED TO LEAK AT THE POINT OF CONNECTION OF THE TUBING AND EXTENSION SET. PHARMACY STAFF EXAMINED THE CONNECTIONS AND THEY WERE TIGHT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10779101 ↗MalfunctionNov 3, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: "THE TREATING NURSE ATTACHED THE BAG TO THE PATIENT AND DRUG [PACLITAXEL] STARTED TO LEAK AT THE POINT OF CONNECTION OF THE TUBING AND EXTENSION SET. PHARMACY STAFF EXAMINED THE CONNECTIONS AND THEY WERE TIGHT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10779099 ↗MalfunctionOct 21, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: "THE TREATING NURSE ATTACHED THE BAG TO THE PATIENT AND DRUG [PACLITAXEL] STARTED TO LEAK AT THE POINT OF CONNECTION OF THE TUBING AND EXTENSION SET. PHARMACY STAFF EXAMINED THE CONNECTIONS AND THEY WERE TIGHT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10714127 ↗MalfunctionMay 14, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 2: THE END USER FOUND A BLACK PARTICULATE IN THE FILTERED EXTENSION SET. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10055797 ↗MalfunctionMay 14, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 1: THE END USER FOUND A BLACK PARTICULATE IN THE FILTERED EXTENSION SET. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10055795 ↗MalfunctionNov 8, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT BLOOD LEAKED DURING PATIENT THERAPY. UPON ROUNDING ON PATIENT TO EVALUATE CENTRAL LINE IT WAS NOTED THAT BLOOD WAS BACKED UP IN TUBING. THE TUBING WAS EXAMINED AND NOTED TO BE BEHIND PATIENT'S BACK. AFTER REPOSITIONING PATIENT IT WAS NOTED THAT TPN LINE HAD BROKEN IN HALF AT AN AREA OF A Y SITE. THE TPN WAS INFUSING INTO THE BED. IT IS UNKNOWN HOW LONG THIS HAD BEEN HAPPENING, HOWEVER THE ENTIRE TOP OF THE BED WAS SATURATED IN TPN AND BLOOD. THE CENTRAL LINE (TLC) THAT THE TPN WAS INFUSING INTO WAS REPLACED THE NEXT DAY.
Patient problems: Venipuncture
MAUDE report 9295125 ↗
Other Set, administration, intravascular devices
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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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