Caresite® 354220Recalls & reported problems
B. Braun Medical Inc. · Standard Bore extension Set with two CARESITE® Injection Sites · Class 2
All models of Caresite (23)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This B. Braun Caresite extension set is an intravenous administration set with injection sites. The 26 reports mostly describe fluid or blood leaking around an injection port or adaptor, along with some resistance and contamination, including a hair sealed into the set. The reports mention no deaths or injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 04046964182358), received between Nov 29, 2016 and Oct 15, 2025 — classified as 26 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (23 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak23
- Physical Resistance/Sticking5
- Contamination /Decontamination Problem1
- Device Contamination with Chemical or Other Material1
- Device Operates Differently Than Expected1
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- No Consequences Or Impact To Patient12
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: DESCRIPTION SUMMARY: THE NURSES FOUND A HAIR SEALED INTO THE IV EXTENSION SET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23304069 ↗MalfunctionJun 22, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 2: DURING CHEMOTHERAPY, END USER OBSERVED THE LEAKING COMING UP AND OUT OF THE CARESITE. INFUSION LEAKS AROUND INJECTION PORT CLOSEST TO PATIENT. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12039802 ↗MalfunctionJun 22, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 1: DURING CHEMOTHERAPY, END USER OBSERVED THE LEAKING COMING UP AND OUT OF THE CARESITE. INFUSION LEAKS AROUND INJECTION PORT CLOSEST TO PATIENT. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12039794 ↗MalfunctionJun 22, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 4: DURING CHEMOTHERAPY, END USER OBSERVED THE LEAKING COMING UP AND OUT OF THE CARESITE. INFUSION LEAKS AROUND INJECTION PORT CLOSEST TO PATIENT. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12039792 ↗MalfunctionJun 22, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 3: DURING CHEMOTHERAPY, END USER OBSERVED THE LEAKING COMING UP AND OUT OF THE CARESITE. INFUSION LEAKS AROUND INJECTION PORT CLOSEST TO PATIENT. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12039791 ↗MalfunctionApr 26, 2021Fluid/Blood Leak; Physical Resistance/Sticking; Fluid/Blood Leak; Physical Resistance/Sticking
AS REPORTED BY THE USER FACILITY: EVENT 4: MESNA AND CYTOXAN VIA PICC.LEAKAGE AT ADAPTOR SITE. MEDICATION WAS CLAMPED OFF. CHEMO SPILL KIT USED. APPROX 500ML OF MESNA AND 200CC OF CYTOXAN REMAINING IN BAGS. PATIENT SAFETY MAINTAINED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11726756 ↗MalfunctionApr 26, 2021Fluid/Blood Leak; Physical Resistance/Sticking; Fluid/Blood Leak; Physical Resistance/Sticking
AS REPORTED BY THE USER FACILITY: EVENT 3: DOXORUBICIN, ETOPOSIDE AND VINCRISTINE INFUSIONS ( ALL CHEMO) WERE STOPPED DUE TO CHEMO LEAKAGE FROM CHEMO ADAPTOR. APPROXIMATELY 300CC REMAINING IN BAG. CHEMO SPILL KIT USED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11726742 ↗MalfunctionApr 26, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 7: IV TUBING REMOVED FROM EXT SET AND TIP NOTED TO BE CRACK. IV FLUIDS RESTARTED ON PRIMARY LINE AND PAC NOTED TO BACK UP BLOOD AND LEAK THROUGH PORT OFEXT SET. PAC FLUSHED WITHOUT COMPLICATIONS AND NEW LINES HUNG. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11726739 ↗MalfunctionApr 26, 2021Fluid/Blood Leak; Physical Resistance/Sticking; Fluid/Blood Leak; Physical Resistance/Sticking
AS REPORTED BY THE USER FACILITY: EVENT 1: IT WAS REPORTED THAT WHILE FLUSHING THE LINE, IT WAS NOTED THAT THE EXTENSION SET WAS LEAKING WHERE THE NEEDLELESS CONNECTOR ATTACHES TO THE IV TUBING. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11726733 ↗MalfunctionApr 26, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 5: METHOTREXATE INFUSING. CHEMOTHERAPY NOTED TO BE LEAKING FROM CAP OF EXT SET. EXT SET NEEDED TO BE REMOVED DURING THERAPY. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11726730 ↗MalfunctionApr 26, 2021Fluid/Blood Leak; Physical Resistance/Sticking; Fluid/Blood Leak; Physical Resistance/Sticking
AS REPORTED BY THE USER FACILITY: EVENT 2: IT WAS REPORTED THAT THE PRODUCT LEAKED CHEMO. THE TUBING WAS FOUND LEAKING AT THE BEDSIDE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11726726 ↗MalfunctionApr 26, 2021Fluid/Blood Leak; Physical Resistance/Sticking; Fluid/Blood Leak; Physical Resistance/Sticking
AS REPORTED BY THE USER FACILITY: EVENT 6: EXT SET INFUSING CHEMOTHERAPY. LEAKING WAS OBSERVED AT CONNECTION SITE. SCANT AMOUNT OF CHEMOTHERAPY LEAKING,EXT SET CHANGED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11726724 ↗MalfunctionFeb 18, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 1: IT WAS REPORTED THAT AS THE RN WAS DRAWING LABS, THE BLOOD BACKED UP FROM THE CENTRAL LINE AND THE CARESITE LEAKED. NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11344233 ↗MalfunctionFeb 18, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 2: IT WAS REPORTED THAT AS THE RN WAS DRAWING LABS, THE BLOOD BACKED UP FROM THE CENTRAL LINE AND THE CARESITE LEAKED. NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11344222 ↗MalfunctionAug 30, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: DURING USE THE SPIN-LOCK CONNECTOR DETACHED/SEPARATED FROM THE EXT. SET IT IS BONDED TO. PEDIATRIC PATIENT IN SURGERY WITH ARMS TUCKED IN. WHEN UNTUCKED THE PATIENT NOTED BLOOD ON THE SHEETS. NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7832521 ↗MalfunctionJul 12, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 2: TUBING SEPARATING FROM DISTAL Y-SITE DURING INFUSION OF SOLUTION. VETERINARY TECHNICIANS NOTICED THAT THE TUBING THAT CONNECTS INTO THE HOUSING OF THE DISTAL Y-SITE WAS SEPARATING JUST BY PULLING LIGHTLY. THE STAFF CAME BACK TO A PATIENT AND NOTICED THE SET HAD SEPARATED EVEN WITHOUT MANUAL MANIPULATION. THIS HAS HAPPENED ON 5 OCCASIONS NOW, BUT THE SETS HAVE BEEN THROWN OUT. THE STAFF WERE CHECKING THE STRENGTH OF EACH SET BEFORE ATTACHING TO A PATIENT TO AVOID ANY ISSUES. IT APPEARS THE SET HAS BEEN EXPOSED TO SOME BLOOD FROM AN ANIMAL. NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7683830 ↗MalfunctionJul 12, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 5: TUBING SEPARATING FROM DISTAL Y-SITE DURING INFUSION OF SOLUTION. VETERINARY TECHNICIANS NOTICED THAT THE TUBING THAT CONNECTS INTO THE HOUSING OF THE DISTAL Y-SITE WAS SEPARATING JUST BY PULLING LIGHTLY. THE STAFF CAME BACK TO A PATIENT AND NOTICED THE SET HAD SEPARATED EVEN WITHOUT MANUAL MANIPULATION. THIS HAS HAPPENED ON 5 OCCASIONS NOW, BUT THE SETS HAVE BEEN THROWN OUT. THE STAFF WERE CHECKING THE STRENGTH OF EACH SET BEFORE ATTACHING TO A PATIENT TO AVOID ANY ISSUES. IT APPEARS THE SET HAS BEEN EXPOSED TO SOME BLOOD FROM AN ANIMAL. NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7683827 ↗MalfunctionJul 12, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 4: TUBING SEPARATING FROM DISTAL Y-SITE DURING INFUSION OF SOLUTION. VETERINARY TECHNICIANS NOTICED THAT THE TUBING THAT CONNECTS INTO THE HOUSING OF THE DISTAL Y-SITE WAS SEPARATING JUST BY PULLING LIGHTLY. THE STAFF CAME BACK TO A PATIENT AND NOTICED THE SET HAD SEPARATED EVEN WITHOUT MANUAL MANIPULATION. THIS HAS HAPPENED ON 5 OCCASIONS NOW, BUT THE SETS HAVE BEEN THROWN OUT. THE STAFF WERE CHECKING THE STRENGTH OF EACH SET BEFORE ATTACHING TO A PATIENT TO AVOID ANY ISSUES. IT APPEARS THE SET HAS BEEN EXPOSED TO SOME BLOOD FROM AN ANIMAL. NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7683826 ↗MalfunctionJul 12, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 3: TUBING SEPARATING FROM DISTAL Y-SITE DURING INFUSION OF SOLUTION. VETERINARY TECHNICIANS NOTICED THAT THE TUBING THAT CONNECTS INTO THE HOUSING OF THE DISTAL Y-SITE WAS SEPARATING JUST BY PULLING LIGHTLY. THE STAFF CAME BACK TO A PATIENT AND NOTICED THE SET HAD SEPARATED EVEN WITHOUT MANUAL MANIPULATION. THIS HAS HAPPENED ON 5 OCCASIONS NOW, BUT THE SETS HAVE BEEN THROWN OUT. THE STAFF WERE CHECKING THE STRENGTH OF EACH SET BEFORE ATTACHING TO A PATIENT TO AVOID ANY ISSUES. IT APPEARS THE SET HAS BEEN EXPOSED TO SOME BLOOD FROM AN ANIMAL. NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7683825 ↗MalfunctionJul 12, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 1: TUBING SEPARATING FROM DISTAL Y-SITE DURING INFUSION OF SOLUTION. VETERINARY TECHNICIANS NOTICED THAT THE TUBING THAT CONNECTS INTO THE HOUSING OF THE DISTAL Y-SITE WAS SEPARATING JUST BY PULLING LIGHTLY. THE STAFF CAME BACK TO A PATIENT AND NOTICED THE SET HAD SEPARATED EVEN WITHOUT MANUAL MANIPULATION. THIS HAS HAPPENED ON 5 OCCASIONS NOW, BUT THE SETS HAVE BEEN THROWN OUT. THE STAFF WERE CHECKING THE STRENGTH OF EACH SET BEFORE ATTACHING TO A PATIENT TO AVOID ANY ISSUES. IT APPEARS THE SET HAS BEEN EXPOSED TO SOME BLOOD FROM AN ANIMAL. NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7683822 ↗MalfunctionJun 21, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT A FOREIGN OBJECT WAS FOUND IN THE IV LINE OF A PATIENT. UNSURE IF THE FOREIGN OBJECT ACTUALLY CAME FROM THE IV LINE OR NOT. A 1000MLS OF NORMAL SALINE WAS BEING INFUSED. NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7626738 ↗MalfunctionSep 13, 2017Fluid/Blood Leak; Fluid/Blood Leak
PER MEDWATCH REPORT NUMBER: (B)(4). EVENT DESCRIPTION: TUBING WAS DISCOVERED TO BE LEAKING AT THE CONNECTION SITE BETWEEN THE BLOOD WARMER CARTRIDGE AND THE IV EXTENSION SET. NO HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6861454 ↗MalfunctionDec 28, 2016Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY USER FACILITY: EVENT 2: LUER ACCESS LEAKS WHEN USED. LEAKING AT THE LUER END WHEN IT IS CONNECTED TO A SYRINGE OF BLOOD THAT WAS BEING PUSHED. BLOOD WAS LEAKING. NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6208356 ↗MalfunctionDec 28, 2016Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY USER FACILITY: EVENT 3. LUER ACCESS LEAKS WHEN USED. LEAKING AT THE LUER END WHEN IT IS CONNECTED TO A SYRINGE OF BLOOD THAT WAS BEING PUSHED. BLOOD WAS LEAKING. NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6208355 ↗MalfunctionDec 28, 2016Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY USER FACILITY: EVENT 1: LUER ACCESS LEAKS WHEN USED. LEAKING AT THE LUER END WHEN IT IS CONNECTED TO A SYRINGE OF BLOOD THAT WAS BEING PUSHED. BLOOD WAS LEAKING. NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6208353 ↗
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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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