Caresite® 354203Recalls & reported problems
B. Braun Medical Inc. · Primary Gravity IV Set with 2 CARESITE® Injection Sites · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04046964182051), received between Jul 3, 2018 and Mar 18, 2026 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (5 reports).
1 FDA recall record name this device's identifier, 1 still open.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Oct 29, 2025Open, Classified
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Z-0625-2026 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak5
- Contamination /Decontamination Problem1
- Device Contamination with Chemical or Other Material1
- Leak/Splash1
Patient problems
- No Known Impact Or Consequence To Patient5
- No Clinical Signs, Symptoms or Conditions2
- No Patient Involvement1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 18, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: A NURSE EMPLOYEE NOTICED A BROWN/BLACK SPEC INSIDE OF THE TUBING OF A NON-FILTERED IV TUBING THAT WAS SEALED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24625922 ↗MalfunctionDec 4, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: LEAKING CHEMO FROM BOTTOM OF DRIP CHAMBER DURING INFUSION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23715071 ↗MalfunctionDec 9, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT DURING CHEMOTHERPHY WITH TAXOL, THE SET LEAKED. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9438907 ↗MalfunctionDec 9, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT DURING CHEMOTHERPHY WITH TAXOL, THE SET LEAKED. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9438897 ↗MalfunctionDec 9, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT DURING CHEMOTHERPHY WITH CLADRIBINE, THE SET LEAKED. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9438895 ↗MalfunctionDec 9, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT DURING CHEMOTHERPHY WITH TAXOL, THE SET LEAKED. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9438894 ↗MalfunctionAug 1, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: AFTER INJECTING THROUGH ONE OF THE CLAVES, THE INTERNAL PART OF THE CLAVE DIDN'T CLOSE OFF, SO FLUID FLOWED FREELY OUT OF IT. THIS IS A HIGH LEVEL CONCERN FOR US BECAUSE WE INJECT RADIOACTIVE SOLUTION INTO THE IV TUBING, AND IF THE CLAVE STAYS OPEN, RADIOACTIVITY SPILLS OUT AND CONTAMINATES THE PATIENT AND AREA. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8850446 ↗MalfunctionJul 3, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT PRIOR TO PRIMING THE SETS, A BLACK FOREIGN MATERIAL WAS SEEN IN THE DRIP CHAMBER. THE DRIP CHAMBER LOOKS DIRTY OVERALL, A COUPLE OF DARK BLACK SPOTS WERE NOTED. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 7661580 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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