Caresite® 415122Recalls & reported problems

Summary

The FDA's MAUDE database contains 152 adverse event reports that list this exact device (DI 04046964115998), received between Nov 18, 2016 and Mar 31, 2026 — classified as 1 death, 151 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (89 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 152 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Crack; Leak/Splash

  AS REPORTED BY THE USER FACILITY: CARESITE CRACKED AND LEAKED DURING A CHEMO INFUSION WHICH LED TO A CHEMO SPILL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24741562 ↗
• 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 24702539 ↗
• MalfunctionFeb 26, 2026Leak/Splash

  PER MEDSUN NUMBER (B)(4): DESCRIBE THE EVENT OR PROBLEM: PATIENT PRESENTED TO INFUSION CENTER FOR CHEMO PUMP D/C [DISCONTINUATION]. UPON ASSESSMENT OF PORT SITE, WHITE DRIED POWDER LEAKING PRESENT ON RIGHT SIDE OF CHEST SKIN, PUMP STRAP AND PATIENT'S BRA AROUND CONNECTION SITE FROM PORT TUBING TO PUMP TUBING. RN EDUCATED PATIENT AND DAUGHTER THAT THIS IS A SIGN OF THE CHEMO LEAKING AND IF IN THE FUTURE ANY DRIED WHITE MATTER IS NOTED TO CALL AND BE SEEN IN INFUSION. PATIENTS SKIN WAS CLEANED WITH SOAP AND WATER AND PATIENT GIVEN A NEW SHIRT TO WEAR HOME. RN REINFORCED EDUCATION ABOUT HAZARDOUS MEDICATIONS AND SPILLS, PATIENT'S EXPOSED CLOTHES WERE BAGGED AND INSTRUCTIONS FOR WASHING TWICE SEPARATELY IN HOT WATER WAS REINFORCED. WHEN PATIENT CHANGED SHIRT, RASH TO CHEST, NECK, UPPER ABDOMEN AND BACK WAS NOTED, RN INSTRUCTED PATIENT TO REPORT THIS AND HAVE THIS SEEN BY PROVIDER AT APPOINTMENT THIS MORNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24460665 ↗
• MalfunctionFeb 23, 2026Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: END USER STATED THAT THERE IS VISIBLE MOLD/FOREIGN OBJECT INSIDE THE EXTENSION SET. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24413197 ↗
• MalfunctionJan 21, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: INCIDENT DESCRIPTION: PT CALLED INTO CARECHART AND STATED THEY HAVE LEAK FROM THEIR 5FU CHEMO BOTTLE @0845. PT STATED THAT THEY TOLD THEM TO COME TO THE CLINIC FOR ASSESSMENT. ON ASSESSMENT THE PATIENT HAD WHITE POWDER ON HER STOMACH AND CHEST, AND SOME LEAKING COMING FROM UNDER THE DRESSING. PT DENIES ANY ITCHINESS, PAIN OR DISCOMFORT WHERE THE CHEMO HAD TOUCHED HER. PT HAD CLAMPED HER PORT AND KINKED THE CHEMO BOTTLE LINE. WRITER UNDRESSED THE DRESSING AND FLUSHED THE PORT LINE. IT APPEARED TO BE LEAKING FROM A CRACK IN THE B. BRAUN CARESITE LUER ACCESS DEVICE. WRITER CHANGED THE CAP AND NO LEAKING OBSERVED AFTER. WRITER ASSESSED THE CHEMO LINE AND DID NOT OBSERVE ANY LEAKING FROM THE BOTTLE OR THE LINE. WRITER CLEANED THE PATIENTS CHEST AND ABDOMEN, CLEANED THE LINES AND REDRESSED THE PORT DRESSING. PT HAD SOME REDNESS AND IRRITATION NOTICED UNDER THE DRESSING. PT RECONNECTED TO THE CHEMO BOTTLE FOR THE REMAINDER OF HER 5FU.

  Patient problems: Chemical Exposure; Rash

  MAUDE report 24130172 ↗
• MalfunctionDec 19, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: PRODUCT ATTACHED TO AN ELASTOMERIC INFUSOR PUMP WHILE RECEIVING TREATMENT AT HOME. CHEMOTHERAPY SPILLED ONTO PATIENT SKIN. PATIENT RETURNED TO CANCER CLINIC AND UPON ASSESSMENT, NOTED CRACK IN CARESITE LUER ACCESS DEVICE. CARESITE CHANGED AND NO FURTHER LEAK OR CRACK FOUND.

  Patient problems: Chemical Exposure

  MAUDE report 23856313 ↗
• MalfunctionDec 4, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A PERQ CATHETER FOR INTRAVENOUS (IV) ACYCLOVIR FOR HERPES SIMPLEX VIRUS (HSV). UPON MORNING ASSESSMENT, THE NURSE (RN) NOTICED THAT THERE WAS BLOOD BACKING UP IN THE PICC LINE TO THE LUERLOCK. WHEN RN MENTIONED SHE WAS GOING TO FLUSH THE PICC LINE, MOM SAID THAT SHE NOTICED A WET SPOT IN HIS BLANKETS EARLIER IN THE MORNING AND THAT SOMETHING MIGHT BE LEAKING. RN CHECKED AND TIGHTENED CONNECTION BETWEEN LUERLOCK AND PICC LINE AND IT WAS ON CORRECTLY. WHEN RN FLUSHED THE PICC LINE, SALINE LEAKED OUT OF LUERLOCK. THE LUERLOCK CAP APPEARED TO BE CRACKED. RN CHANGED THE LUERLOCK CAP ON PICC LINE, BUT BECAUSE THE CONTINUOUS HEPARIN HAD BEEN LEAKING OUT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23715024 ↗
• MalfunctionNov 14, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DURING THERAPY PATIENT HAD AN INFUSION CONTAINING FLUORDURACIL IN HIS PICC, ON THE SECOND NIGHT PATIENT REPORTED LEAKING OF DRUG. ON INSPECTION A CRACK/LEAK WAS OBSERVED IN THE BUNG THAT WAS ATTACHED TO THE PATIENTS PICC LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555061 ↗
• MalfunctionNov 5, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DURING THERAPY THE DEVICE RETURNED BLOOD. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23476646 ↗
• MalfunctionOct 17, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: BLOOD RETURN IS SEEN, WHICH SHOULD NOT HAPPEN, CREATING A RISK OF CONTAMINATION FOR HEALTHCARE PERSONNEL. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23328099 ↗
• MalfunctionMay 6, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: THE INSIDE OF THE VALVE CONNECTOR HOUSING IS DISCOLORED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21972357 ↗
• MalfunctionApr 1, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE B. BRAUN GLOBAL AFFILIATE: WE HAVE ANOTHER BUNG FOUND WITH THE SAME ISSUE DELIVERING CHEMOTHERAPY. CAN WE PLEASE HAVE ANOTHER BOX SENT TO 97 HARLEY STREET SO WE CAN SEND THIS OVER. THIS BUNG HAS BEEN CONTAMINATED WITH CHEMOTHERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21738219 ↗
• MalfunctionMar 31, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE B.BRAUN GLOBAL AFFILIATE: I WANTED TO BRING TO YOUR ATTENTION AN ISSUE REGARDING THE BUNGS FROM THE BATCH NUMBER. UNFORTUNATELY, WE'VE ENCOUNTERED FAULTS WITH THESE BUNGS, AND THIS APPEARS TO BE A RECURRING PROBLEM, RATHER THAN AN ISOLATED INCIDENT. I CAN CONFIRM THAT I HAVE THREE BOXES WITH THE BATCH NUMBER OF THE FAULTY BUNGS. BATCH NO. 0061966919 I'M REALLY CONCERNED ABOUT PATIENT SAFETY, AS WE ADMINISTER CHEMOTHERAPY, AND ANY LEAKAGE FROM THESE BUNGS COULD CAUSE HARM TO OUR PATIENTS. CAN WE URGENTLY LOOK INTO THIS? UPDATE FROM CUSTOMER; IN TERMS OF THE 3 INCIDENTS YOU MENTION, WERE THESE ALL EXPERIENCED USING BUNGS FROM THE SAME BATCH NO. 0061966919? - YES. 1. WAS THERE ANY PATIENT/USER HARM BECAUSE OF THE INCIDENT? IF SO, PLEASE PROVIDE FURTHER CLINICAL INFORMATION SUCH AS PATIENT OUTCOME AND ANY ADDITIONAL THERAPY REQUIRED AS A RESULT. - NO HARM. 2. WHICH PROCEDURE WAS BEING CARRIED OUT AT THE TIME? - PICC DRESSING CHANGE. 3. WAS THERE ANY DELAY TO THE PROCEDURE BECAUSE OF THIS INCIDENT? IF SO, PLEASE QUANTIFY AS ACCURATELY AS POSSIBLE. - NO SIGNIFICANT DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21731228 ↗
• MalfunctionMar 19, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: ISSUE DELIVERING CHEMOTHERAPY. WAS THERE ANY PATIENT/USER HARM BECAUSE OF THE INCIDENT? IF SO, PLEASE PROVIDE FURTHER CLINICAL INFORMATION SUCH AS PATIENT OUTCOME AND ANY ADDITIONAL THERAPY REQUIRED AS A RESULT. YES. PATIENT WAS CONNECTED TO CHEMOTHERAPY TREATMENT WHICH WAS TO BE INFUSED OVER 48 HOURS. CHEMOTHERAPY TREATMENT HAD LEAKED ONTO PATIENT. CYTOTOXIC DRUG EXPOSED TO PATIENT. REQUIRED ASSISTANCE FROM 24 HOUR TRIAGE LINE AND TREATMENT WAS STOPPED UNTIL PATIENT COULD ATTEND THE FOLLOWING DAY. PATIENT TREATMENT DELAYED ANOTHER 24 HOURS FOR FULL COMPLETION. WHICH PROCEDURE WAS BEING CARRIED OUT AT THE TIME? DELIVERY OF 48 HOUR CHEMOTHERAPY INFUSION. WAS THERE ANY DELAY TO THE PROCEDURE BECAUSE OF THIS INCIDENT? IF SO, PLEASE QUANTIFY AS ACCURATELY AS POSSIBLE. YES. PATIENT TREATMENT WAS DELAYED BY ADDITIONAL 24 HOURS. WAS THERE ANY PATIENT/USER HARM BECAUSE OF THE INCIDENT? IF SO, PLEASE PROVIDE FURTHER CLINICAL INFORMATION SUCH AS PATIENT OUTCOME AND ANY ADDITIONAL THERAPY REQUIRED AS A RESULT. NO PATIENT/USER HARM. LEAK WAS VISIBLY NOTED BY STAFF. WHICH PROCEDURE WAS BEING CARRIED OUT AT THE TIME? ANTIBIOTIC ADMINISTRATION AND PORTACATH FLUSH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21645568 ↗
• MalfunctionMar 19, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: CARESITE LEAKED CHEMO. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21645564 ↗
• MalfunctionMar 19, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: DURING THERAPY FOREIGN MATTER WAS OBSERVED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21645405 ↗
• MalfunctionMar 19, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: ISSUE DELIVERING CHEMOTHERAPY. WAS THERE ANY PATIENT/USER HARM BECAUSE OF THE INCIDENT? IF SO, PLEASE PROVIDE FURTHER CLINICAL INFORMATION SUCH AS PATIENT OUTCOME AND ANY ADDITIONAL THERAPY REQUIRED AS A RESULT. YES. PATIENT WAS CONNECTED TO CHEMOTHERAPY TREATMENT WHICH WAS TO BE INFUSED OVER 48 HOURS. CHEMOTHERAPY TREATMENT HAD LEAKED ONTO PATIENT. CYTOTOXIC DRUG EXPOSED TO PATIENT. REQUIRED ASSISTANCE FROM 24 HOUR TRIAGE LINE AND TREATMENT WAS STOPPED UNTIL PATIENT COULD ATTEND THE FOLLOWING DAY. PATIENT TREATMENT DELAYED ANOTHER 24 HOURS FOR FULL COMPLETION. WHICH PROCEDURE WAS BEING CARRIED OUT AT THE TIME? DELIVERY OF 48 HOUR CHEMOTHERAPY INFUSION. WAS THERE ANY DELAY TO THE PROCEDURE BECAUSE OF THIS INCIDENT? IF SO, PLEASE QUANTIFY AS ACCURATELY AS POSSIBLE. YES. PATIENT TREATMENT WAS DELAYED BY ADDITIONAL 24 HOURS. WAS THERE ANY PATIENT/USER HARM BECAUSE OF THE INCIDENT? IF SO, PLEASE PROVIDE FURTHER CLINICAL INFORMATION SUCH AS PATIENT OUTCOME AND ANY ADDITIONAL THERAPY REQUIRED AS A RESULT. NO PATIENT/USER HARM. LEAK WAS VISIBLY NOTED BY STAFF. WHICH PROCEDURE WAS BEING CARRIED OUT AT THE TIME? ANTIBIOTIC ADMINISTRATION AND PORTACATH FLUSH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21645281 ↗
• MalfunctionFeb 21, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: CLEARLY DEMONSTRATED THAT THE 5-FU LEAK WAS FROM THE BUNG ON THE PUMP. NO CONTACT WAS MADE WITH HIS SKIN, HE WAS ASYMPTOMATIC AND HAD NORMAL OBSERVATIONS. THE PORT WAS HEALTHY WITH NO EVIDENCE OF A REACTION. CLINICAL UPDATE: WAS THERE ANY PATIENT/USER HARM BECAUSE OF THE INCIDENT? IF SO, PLEASE PROVIDE FURTHER CLINICAL INFORMATION SUCH AS PATIENT OUTCOME AND ANY ADDITIONAL THERAPY REQUIRED AS A RESULT. NO CONTACT WAS MADE WITH HIS SKIN, HE WAS ASYMPTOMATIC AND HAD NORMAL OBSERVATIONS. THE PORT WAS HEALTHY WITH NO EVIDENCE OF A REACTION. WHICH PROCEDURE WAS BEING CARRIED OUT AT THE TIME? CONTINUOUS 48 HOUR INFUSION VIA PUMP. WAS THERE ANY DELAY TO THE PROCEDURE BECAUSE OF THIS INCIDENT? IF SO, PLEASE QUANTIFY AS ACCURATELY AS POSSIBLE. YES, PATIENT TREATMENT WAS STOPPED UNTIL ABLE TO ATTEND THE FOLLOWING DAY. DELAY APPROX. 12 HOURS. IS THERE A SAMPLE AVAILABLE TO COLLECT? YES, SAMPLE WAS KEPT IN ASEPTIC'S UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21432258 ↗
• MalfunctionFeb 3, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 5: WE'VE HAD SEVERAL INSTANCES OVER THE LAST WEEK OF CHEMO PUMPS PATIENTS WEAR TO TAKE HOME LEAKING DUE TO FAULTY BUNGS. WE ARE QUITE SURE OF THE CAUSE, AS THE BUNG ISN'T LEAKING WHEN THE PATIENT IS ON THE UNIT WITH US, BUT HAPPENING WHEN THEY GO HOME WITH THE PUMP ATTACHED FOR A 48 HOUR PERIOD. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21297697 ↗
• MalfunctionFeb 3, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 1: WE'VE HAD SEVERAL INSTANCES OVER THE LAST WEEK OF CHEMO PUMPS PATIENTS WEAR TO TAKE HOME LEAKING DUE TO FAULTY BUNGS. WE ARE QUITE SURE OF THE CAUSE, AS THE BUNG ISN'T LEAKING WHEN THE PATIENT IS ON THE UNIT WITH US, BUT HAPPENING WHEN THEY GO HOME WITH THE PUMP ATTACHED FOR A 48 HOUR PERIOD. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21297651 ↗
• MalfunctionFeb 3, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 4: WE'VE HAD SEVERAL INSTANCES OVER THE LAST WEEK OF CHEMO PUMPS PATIENTS WEAR TO TAKE HOME LEAKING DUE TO FAULTY BUNGS. WE ARE QUITE SURE OF THE CAUSE, AS THE BUNG ISN'T LEAKING WHEN THE PATIENT IS ON THE UNIT WITH US, BUT HAPPENING WHEN THEY GO HOME WITH THE PUMP ATTACHED FOR A 48 HOUR PERIOD. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21297649 ↗
• MalfunctionFeb 3, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 2: WE'VE HAD SEVERAL INSTANCES OVER THE LAST WEEK OF CHEMO PUMPS PATIENTS WEAR TO TAKE HOME LEAKING DUE TO FAULTY BUNGS. WE ARE QUITE SURE OF THE CAUSE, AS THE BUNG ISN'T LEAKING WHEN THE PATIENT IS ON THE UNIT WITH US, BUT HAPPENING WHEN THEY GO HOME WITH THE PUMP ATTACHED FOR A 48 HOUR PERIOD. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21297648 ↗
• MalfunctionFeb 3, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 3: WE'VE HAD SEVERAL INSTANCES OVER THE LAST WEEK OF CHEMO PUMPS PATIENTS WEAR TO TAKE HOME LEAKING DUE TO FAULTY BUNGS. WE ARE QUITE SURE OF THE CAUSE, AS THE BUNG ISN'T LEAKING WHEN THE PATIENT IS ON THE UNIT WITH US, BUT HAPPENING WHEN THEY GO HOME WITH THE PUMP ATTACHED FOR A 48 HOUR PERIOD. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21297647 ↗
• MalfunctionJan 3, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: USER NOTICED BLOOD TRACKING UP CVAD AND INTO 415122, THEN OBSERVED BLOOD AND FLUID LEAKING, WHICH THEY PRESUMED WAS COMING FROM 415122. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21067094 ↗
• MalfunctionDec 5, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: COMPLAINT: WHILE ADMINISTERING ANTI-CANCER DRUGS, THE MEDICAL SOLUTION LEAKED FROM SOMEWHERE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18271172 ↗