Caresite® 470100Recalls & reported problems
B. Braun Medical Inc. · CARESITE® Needleless Connector, 8" Bonded High Pressure Small Bore Extension Set · Class 2
Quick summary
This B. Braun Caresite needleless connector is a small-bore extension set used to access IV and PICC lines for infusions. The 47 reports mostly describe leaking — blood and IV fluid or chemotherapy leaking out at the connector, sometimes onto the patient — plus some contamination and blood backing up into the end cap. There are no deaths and 1 injury. 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
- 46
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 04046964093715), received between Dec 28, 2016 and Mar 26, 2026 — classified as 1 injury, 45 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (31 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash31
- Fluid/Blood Leak13
- Contamination /Decontamination Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- Hemorrhage/Blood Loss/Bleeding12
- No Consequences Or Impact To Patient7
- Chemical Exposure3
- No Known Impact Or Consequence To Patient2
- Blood Loss1
- Low Blood Pressure/ Hypotension1
Recent adverse event reports
The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY. THE CARESITE LUER ACCESS DEVICE ATTACHED TO PATIENT'S PICC LINE NOTED TO BE LEAKING BLOOD AND IV FLUID. UPON INSPECTION AND FLUSHING WITH NORMAL SALINE SYRINGE, THE LEAK WAS ISOLATED TO THE LUER ACCESS DEVICE ITSELF. NO INJURY REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 24702540 ↗MalfunctionMar 26, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: CARESITE LUER ACCESS DEVICE ATTACHED TO PATIENT'S PICC LINE NOTED TO BE LEAKING BLOOD AND IV FLUID. UPON INSPECTION AND FLUSHING WITH NORMAL SALINE SYRINGE, THE LEAK WAS ISOLATED TO THE LUER ACCESS DEVICE ITSELF. NEW LUER ACCESS DEVICE PLACED, AND OLD DEVICE REMOVED FROM PICC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24702534 ↗MalfunctionJan 22, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: THE BUNG OF THE CARESITE DEVICE FAILED DURING THERAPY, RESULTING IN CHEMOTHERAPY SOLUTION LEAKING ONTO THE PATIENT. NO INJURY REPORTED.
Patient problems: Chemical Exposure
MAUDE report 24157623 ↗MalfunctionJan 22, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: THE BUNG OF THE CARESITE DEVICE FAILED DURING THERAPY, RESULTING IN CHEMOTHERAPY SOLUTION LEAKING ONTO THE PATIENT. NO INJURY REPORTED.
Patient problems: Chemical Exposure
MAUDE report 24157218 ↗MalfunctionJan 22, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: DURING THERAPY THE BUNG FAILED RESULTING IN CHEMOTHERAPY LEAKING ONTO THE PATIENT.
Patient problems: Chemical Exposure
MAUDE report 24156572 ↗MalfunctionNov 26, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: TRIED TO FLUSH SITE AND IT LEAKED AT THE LUER LOCK END. IT WAS NOT THE SALINE FLUSH THAT WAS MALFUNCTIONING. NO INJURY REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23655883 ↗MalfunctionNov 14, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 2: ON TWO EXTENSION SETS BLOOD BACKED UP INTO THE END CAP ON TWO DIFFERENT PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23556841 ↗MalfunctionNov 14, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 1: ON TWO EXTENSION SETS BLOOD BACKED UP INTO THE END CAP ON TWO DIFFERENT PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23556840 ↗MalfunctionAug 7, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: IV CATHETER EXTENSION TUBING IS FAULTY, BECAME DISCONNECTED WHEN REMOVING A SALINE FLUSH FROM LINE. EXTENSION IMMEDIATELY BEGAN TO FILL WITH BLOOD. RN WAS PRESENT AND ABLE TO STOP BLEEDING IMMEDIATELY, REATTACH LUER LOCK AND FLUSH THE LINE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22739795 ↗MalfunctionJul 18, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: DESCRIPTION OF THE PATIENT EVENT: CUSTOMER STATES THAT EXTENSION SET STARTED LEAKING FROM THE CAP AND WILL FLUID STOPPED, BLOOD BEGAN TO LEAK FROM CAP. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22541200 ↗MalfunctionDec 30, 2024Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: BLOOD OR OTHER LIQUIDS LEAK FROM THE VALVE EITHER DURING USE OR WHEN THE VALVE IS NO LONGER IN USE (RINSING IS PERFORMED AT THE END OF USE). NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21039422 ↗MalfunctionOct 8, 2024Leak/Splash; Leak/Splash
AS REPORTED, PATIENT WAS GETTING UNDRESSED AND HAS DISLODGED THE EXTENSION SET OFF THE PERIPHERAL INTRAVENOUS CATHETERS (PIVC). IMMEDIATELY NOTED AND BLEEDING CONTROLLED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 20397870 ↗InjuryOct 3, 2024Leak/Splash; Leak/Splash
AS REPORTED, PATIENT (PT) INDEPENDENT WITH MOBILISING FROM BED TO BATHROOM. PT TOOK SELF TO BATHROOM WITH IV FLUIDS AND IV POLE. ON WAY BACK TO BED HAS BECOME DISCONNECTED FROM THE PERIPHERAL INTRAVENOUS CATHETER (PIVC). PT HAS NOT NOTICED. AS WAS INDEPENDENT HAS NOT BEEN ASSISTED BACK TO BED. PT WENT BACK TO SLEEP. ASSITANT IN NURSING (AIN) HAS NOTED THE SMELL OF COPPER AND ON INVESTIGATION HAS SEEN SIGNIFICANT BLOOD LOSS IN THE BED AND FLOOR NEXT TO BED. ESCALATED IMMEDIATELY. BLEEDING CONTROLLING. MET CALL INITIATED. PT REQUIRED 2X PACKED RED BLOOD CELLS (PRBC). BLOODPRESSURE (BP) DROP TO 70SYS, PALE. RECOVERED WELL.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension
MAUDE report 20362457 ↗MalfunctionJul 2, 2024Leak/Splash; Leak/Splash
AS REPORTED BY THE B. BRAUN MEDICAL GLOBAL AFFILIATE: COMPLAINT: DURING AN IV DRIP, THE CONNECTION BETWEEN THE TUBE AND THE CONNECTOR DETACHED, CAUSING BLOOD TO LEAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19655794 ↗MalfunctionJun 19, 2024Leak/Splash; Leak/Splash
AS REPORTED BY THE B. BRAUN AFFILIATE: COMPLAINT: LIQUID LEAKED FROM THE CONNECTION. CRACK WAS FOUND AT THE CONNECTOR. THE DRUG ADMINISTERED WAS METHOTREXATE (AN ANTICANCER DRUG). WE HAVE RECEIVED REQUESTS FROM CUSTOMERS TO GET THE RESULTS OF THEIR INVESTIGATIONS AS SOON AS POSSIBLE. NO INFECTION/NO HEALTH HAZARD TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19570214 ↗MalfunctionDec 15, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 5: WE ARE HAVING ISSUES WITH CARESITE SMALLBORE EXTENSION SET (470100-01) DETACHING FROM IV CANNULAS. ON SPEAKING TO THE CUSTOMER SHE GAVE ME FURTHER INFORMATION. THIS HAS HAPPENED 5 TIMES THE FIRST TIME THE BABY LOST A SIGNIFICANT AMOUNT OF BLOOD AND THE BABIES HEMOGLOBIN LEVEL DROPPED BY HALF. THE HOSPITAL HAS NOT EXPERIENCED ANY FURTHER INJURIES, AS FAR AS THE NURSE KNOWS.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 18337005 ↗MalfunctionDec 15, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 4: WE ARE HAVING ISSUES WITH CARESITE SMALLBORE EXTENSION SET (470100-01) DETACHING FROM IV CANNULAS. ON SPEAKING TO THE CUSTOMER SHE GAVE ME FURTHER INFORMATION. THIS HAS HAPPENED 5 TIMES THE FIRST TIME THE BABY LOST A SIGNIFICANT AMOUNT OF BLOOD AND THE BABIES HEMOGLOBIN LEVEL DROPPED BY HALF. THE HOSPITAL HAS NOT EXPERIENCED ANY FURTHER INJURIES, AS FAR AS THE NURSE KNOWS.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 18336989 ↗MalfunctionDec 15, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 3: WE ARE HAVING ISSUES WITH CARESITE SMALLBORE EXTENSION SET (470100-01) DETACHING FROM IV CANNULAS. ON SPEAKING TO THE CUSTOMER SHE GAVE ME FURTHER INFORMATION. THIS HAS HAPPENED 5 TIMES THE FIRST TIME THE BABY LOST A SIGNIFICANT AMOUNT OF BLOOD AND THE BABIES HEMOGLOBIN LEVEL DROPPED BY HALF. THE HOSPITAL HAS NOT EXPERIENCED ANY FURTHER INJURIES, AS FAR AS THE NURSE KNOWS.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 18336973 ↗MalfunctionDec 15, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 2: WE ARE HAVING ISSUES WITH CARESITE SMALLBORE EXTENSION SET (470100-01) DETACHING FROM IV CANNULAS. ON SPEAKING TO THE CUSTOMER SHE GAVE ME FURTHER INFORMATION. THIS HAS HAPPENED 5 TIMES THE FIRST TIME THE BABY LOST A SIGNIFICANT AMOUNT OF BLOOD AND THE BABIES HEMOGLOBIN LEVEL DROPPED BY HALF. THE HOSPITAL HAS NOT EXPERIENCED ANY FURTHER INJURIES, AS FAR AS THE NURSE KNOWS.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 18336968 ↗MalfunctionDec 15, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 1: WE ARE HAVING ISSUES WITH CARESITE SMALLBORE EXTENSION SET (470100-01) DETACHING FROM IV CANNULAS. ON SPEAKING TO THE CUSTOMER SHE GAVE ME FURTHER INFORMATION. THIS HAS HAPPENED 5 TIMES THE FIRST TIME THE BABY LOST A SIGNIFICANT AMOUNT OF BLOOD AND THE BABIES HEMOGLOBIN LEVEL DROPPED BY HALF. THE HOSPITAL HAS NOT EXPERIENCED ANY FURTHER INJURIES, AS FAR AS THE NURSE KNOWS.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 18336958 ↗MalfunctionNov 2, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: RN DISCONNECTED IV TUBING FROM ACCESS DEVICE AND UPON ATTEMPTING TO FLUSH, REALIZED BLOOD WAS BACKING UP AND LEAKING OUT OF CONNECTOR - CLAMP ON SET DID NOT STOP BLOOD FLOW, USED HEMSTAT TO CLAMP AND REPLACE ACCESS DEVICE. UPON INSPECTION, SHE NOTICED THE SPIN LOCK CONNECTOR WAS FAULTY. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15713384 ↗MalfunctionJun 22, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: THE TUBE CAME OFF WHEN THE USER TRIED TO MAKE A CONNECTION DURING USE. IT IS A PLACE THAT IS ORIGINALLY CONNECTED AND CANNOT BE REMOVED. THE USER SAYS THE CONNECTOR IS LOOSE AND COME OFF. THIS SAMPLE WAS USED FOR AN ANTI-CANCER AGENT (5FU). NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14774555 ↗MalfunctionJun 16, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: WHEN THE USER CONNECTED THE INFUSION SET AND WAS ADMINISTERING THE ANTICANCER DRUG (5FU), THE DRUG SOLUTION LEAKED FROM THE CONNECTION PART. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14711928 ↗MalfunctionJun 16, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: LEAKAGE OCCURRED WHILE ADMINISTERING AN ANTICANCER DRUG (ABRAXANE). THE LEAKED PART IS UNKNOWN. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14711918 ↗MalfunctionApr 13, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT UPON REMOVING A TUBING FROM THE NEEDLELESS CONNECTOR, THE TUBING BROKE OFF INTO THE CARESITE CONNECTOR. THE ENTIRE EXTENSION SET REQUIRED REMOVAL AND REPLACEMENT. FORTUNATELY, THE NURSE WAS ABLE TO SAVE THE IV LINE. THE PATIENT HAD A LARGE AMOUNT OF BLOOD FLOWING FROM THE BROKEN CONNECTOR. NO INJURY REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 14101838 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.