Extension Set 470195Recalls & reported problems
B. Braun Medical Inc. · EXT.SET 2 CARESITE LADS, 29 IN. · Class 2
All models of Extension Set (41)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04046964823428), received between Jun 16, 2017 and Jun 22, 2021 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (10 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 18, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak10
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Consequences Or Impact To Patient3
- Chemical Exposure2
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
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 12039795 ↗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 12039793 ↗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 12039790 ↗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 12039787 ↗MalfunctionNov 16, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: BLOOD BACKED UP IN AN IV LINE. WHEN THE LINE WAS FLUSHED, IT LEAKED FROM ONE OF THE PORTS OF THE EXTENSION SET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10843830 ↗MalfunctionMar 19, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS TWO (2) CHEMOTHERAPY INCIDENTS. EVENT 1: IT WAS REPORTED THAT DURING CHEMOTHERAPY OF BUSULFAN, THE PRODUCT LEAKED. THE LOWER Y-SITE LEAKED. CHEMO LEAKED ON PATIENTS ARM, SHIRT AND BED. NO INJURY REPORTED. EVENT 2, WILL BE REPORTED VIA MFR REPORT NUMBER: 2523676-2020-00081 FOR THE SECOND EVENT, IT WAS REPORTED THAT THE NURSE NOTED THAT THE PRODUCT WAS LEAKING. THE LINE WAS PAUSED AND CHANGED. CHEMOTHERAPY DRUG INVOLVED WAS NOT PROVIDED. NO INJURY REPORTED.
Patient problems: Chemical Exposure; No Known Impact Or Consequence To Patient
MAUDE report 9852797 ↗MalfunctionMar 19, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS TWO (2) CHEMOTHERAPY INCIDENTS. EVENT 2: IT WAS REPORTED THAT THE NURSE NOTED THAT THE PRODUCT WAS LEAKING. THE LINE WAS PAUSED AND CHANGED. CHEMOTHERAPY DRUG INVOLVED WAS NOT PROVIDED. NO INJURY REPORTED. EVENT 1: WAS REPORTED VIA MFR REPORT NUMBER: 2523676-2020-00080. IT WAS REPORTED THAT DURING CHEMOTHERAPY OF BUSULFAN, THE PRODUCT LEAKED. THE LOWER Y-SITE LEAKED. CHEMO LEAKED ON PATIENTS ARM, SHIRT AND BED. NO INJURY REPORTED.
Patient problems: Chemical Exposure; No Known Impact Or Consequence To Patient
MAUDE report 9852794 ↗MalfunctionJul 25, 2017Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: DURING INFUSION OF LEUCOVORIN AND CHEMOTHERAPY WITH CYTARABINE, THE EXTENSION SET LEAKED. NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6740555 ↗MalfunctionJun 16, 2017Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 2: TUBING LEAKING DURING CHEMOTHERAPY. NURSE WAS RUNNING METHOTREXATE ON PEDIATRIC ONCOLOGY FLOOR AND SET 470195 WAS OBSERVED TO BE LEAKING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6648900 ↗MalfunctionJun 16, 2017Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 1: TUBING LEAKING DURING CHEMOTHERAPY. NURSE WAS RUNNING METHOTREXATE ON PEDIATRIC ONCOLOGY FLOOR AND SET (B)(4) WAS OBSERVED TO BE LEAKING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6648898 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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