Caresite® 354207Recalls & reported problems
B. Braun Medical Inc. · Primary Gravity Filtered Set with 2 CARESITE® Injection Sites · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04046964182136), received between Apr 21, 2018 and Mar 12, 2026 — classified as 13 malfunctions.
The most frequently reported specific device problem is “Air/Gas in Device” (6 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-0626-2026 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Air/Gas in Device6
- Fluid/Blood Leak4
- Leak/Splash4
- Improper Flow or Infusion1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- No Known Impact Or Consequence To Patient3
- Hemorrhage/Blood Loss/Bleeding2
- Blood Loss1
- Dizziness1
- No Consequences Or Impact To Patient1
- Syncope/Fainting1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 12, 2026Leak/Splash; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): SETS ARE LEAKING AND AIR IS GETTING INTO THE LINE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24578418 ↗MalfunctionDec 30, 2024Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): BUBBLES IN THE LINES. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21036380 ↗MalfunctionOct 16, 2024Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device
AS REPORTED, AIR COMES BACK THROUGH THE BOTTOM IF NOT HANGING IN A SPECIFIC WAY. THE LINES WILL DRIP FLUID OFTEN (ESPECIALLY IF HUNG IN THE WAY NEEDED TO AVOID THE AIR COMING THROUGH THE LINE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20461183 ↗MalfunctionOct 9, 2024Leak/Splash; Leak/Splash
AS REPORTED, CUSTOMER HAD A LEAKING INCIDENT WHEN INFUSING PACLITAXEL WITH OUR SAFEDAY TUBING #354207.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20409011 ↗MalfunctionOct 7, 2024Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 2: DETAILS OF COMPLAINT (REPORTED ISSUE): THE LINES ARE LEAKING EVEN WHEN FULLY CLOSED. WHEN WE INCREASE THE FLOW TO STOP THE LEAKING, AIR ENTERS THE LINE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20384138 ↗MalfunctionOct 7, 2024Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 1: DETAILS OF COMPLAINT (REPORTED ISSUE): THE LINES ARE LEAKING EVEN WHEN FULLY CLOSED. WHEN WE INCREASE THE FLOW TO STOP THE LEAKING, AIR ENTERS THE LINE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20384087 ↗MalfunctionJun 12, 2024Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): PROBLEM INFORMATION BUBBLES IN THE IV LINE "THE BUBBLES ARE FORMING PRE AND POST THE FILTER. I AM SUSPICIOUS THEY ARE COMING FROM THE INJECTION PORTS AS I CAN HEAR A "FIZZ" SOUND, BUT I ALSO THINK IT'S HAPPENING AT THE FILTER AS WELL. I CAN PRIME THE WHOLE LINE WITHOUT BUBBLES AND THEN NEW ONE'S FORM WHILE I AM RUNNING A DRIP. I AM NOT USING THE INJECTION PORTS, SO THIS IS JUST WHILE RUNNING AN IV BAG FROM THE TOP" OCCURRENCES: 1 EA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19519237 ↗MalfunctionNov 27, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: BLOOD BACK FLOW, LEAKING. DETAILED INQUIRY DESCRIPTION: FROM CUSTOMER: IV TUBING USED WAS THE BRAUN 0.2 LINE LOT 0061829317 AND BRAUN FLOW REGULATOR SET LOT 221501L. PATIENT WAS CONNECTED TO IV LINE POST IV INSERTION, BLOOD FLOWED BACK UP THE TUBING (TOURNIQUET WAS OFF), AND THEN CONTINUED TO LEAK OUT OF TUBING. PATIENT WAS DISCONNECTED AND I CONNECTED THEM TO A SALINE LOCK WHICH I LUCKILY HAD RIGHT BESIDE ME. PATIENT DID GO VASOVAGAL WITH LIGHT HEADINESS, AND LOOKED SLIGHTLY PALE. I BELIEVE THE LEAK WAS WITH THE IV TUBING AND NOT FLOW REGULATOR BUT I COULD NOT EXACTLY PINPOINT AT WHAT SITE. MY FIRST THOUGHT WHEN I NOTICED THE BLOOD FLOW RETURN WAS THE CONNECTION WAS LOOSE BUT WHEN I TIGHTENED IT CONTINUED TO FLOW UPWARDS THEN STARTED LEAKING.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Syncope/Fainting
MAUDE report 18208444 ↗MalfunctionNov 16, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): PATIENT WAS CONNECTED TO IV LINE POST IV INSERTION, BLOOD FLOWED BACK UP THE TUBING (TOURNIQUET WAS OFF), AND THEN CONTINUED TO LEAK OUT OF TUBING. PATIENT WAS DISCONNECTED AND I CONNECTED THEM TO A SALINE LOCK WHICH I LUCKILY HAD RIGHT BESIDE ME. PATIENT DID GO VASOVAGAL WITH LIGHT HEADINESS AND LOOKED SLIGHTLY PALE. I BELIEVE THE LEAK WAS WITH THE IV TUBING AND NOT FLOW REGULATOR, BUT I COULD NOT EXACTLY PINPOINT AT WHAT SITE. MY FIRST THOUGHT WHEN I NOTICED THE BLOOD FLOW RETURN WAS THE CONNECTION WAS LOOSE BUT WHEN I TIGHTENED IT CONTINUED TO FLOW UPWARDS THEN STARTED LEAKING.
Patient problems: Dizziness; Hemorrhage/Blood Loss/Bleeding
MAUDE report 18151310 ↗MalfunctionMay 14, 2020Improper Flow or Infusion; Improper Flow or Infusion
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS AIR IN LINE DURING USE. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10055802 ↗MalfunctionApr 4, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 1: CUSTOMER REPORTS THAT THE FILTER LEAKED. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8484491 ↗MalfunctionApr 4, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 2: CUSTOMER REPORTS THAT THE FILTER LEAKED. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8484465 ↗MalfunctionApr 21, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: DURING INFUSION THE IV SET BEGAN LEAKING AT THE CONNECTION OF TUBING AND LOWER Y-PORT. PATIENT WAS BEING INFUSED (UNKNOWN SOLUTION), DENIES CHEMO AGENT. PATIENTS' BLOOD STARTED BACKING UP IN SET, A LITTLE WAS STARTING TO COME OUT. THE NURSE STOPPED THE INFUSION IMMEDIATELY AND CHANGED OUT THE SET WITH A NEW IV SET. THE PATIENT'S PERIPHERAL IV CATHETER WAS INTACT AND DID NOT NEED TO BE CHANGED OUT. NURSE RECONNECTED A NEW INFUSION AND PATIENT RECEIVED FULL THERAPEUTIC DOSE. NO INJURIES REPORTED.
Patient problems: Blood Loss; No Consequences Or Impact To Patient
MAUDE report 7449674 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.