Extension Set 470073Recalls & reported problems
B. Braun Medical Inc. · EXT SET W/ 0.2 MICRON FILTER 9 IN. · Class 2
All models of Extension Set (41)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04046964298219), received between Dec 11, 2018 and Feb 17, 2026 — classified as 11 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak9
- Contamination /Decontamination Problem1
- Leak/Splash1
Patient problems
- No Known Impact Or Consequence To Patient7
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 17, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: END USER REPORTS A LEAKING FILTER EXTENSION SET (REF 470073). IT WAS LEAKING CHEMO IN BETWEEN THE LUER CONNECTOR AND TUBING. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24372960 ↗MalfunctionJul 26, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: ACCORDING TO THE CUSTOMER, THE FILTERS THEY RECENTLY PURCHASED HAVE A POWDER IN THEM, WHICH DARKENS AS DRUG IS INFUSED AND THEY ARE ALSO PRECIPITATING. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17395828 ↗MalfunctionAug 12, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT DURING CHEMOTHERAPY BLINATUMOMAB, THE FILTER LEAKED. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10397413 ↗MalfunctionSep 17, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 2: IT WAS REPORTED THAT THE FILTER LEAKED DURING CHEMO USE. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9075100 ↗MalfunctionSep 17, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 1: IT WAS REPORTED THAT THE FILTER LEAKED DURING CHEMO USE. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9075096 ↗MalfunctionSep 17, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 5: IT WAS REPORTED THAT THE FILTER LEAKED DURING CHEMO USE. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9075095 ↗MalfunctionSep 17, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 3: IT WAS REPORTED THAT THE FILTER LEAKED DURING CHEMO USE. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9075093 ↗MalfunctionSep 17, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 4: IT WAS REPORTED THAT THE FILTER LEAKED DURING CHEMO USE. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9075091 ↗MalfunctionAug 6, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS THAT THE MICRON FILTER LEAKED CHEMOTHERAPY DRUG. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8863809 ↗MalfunctionDec 11, 2018Fluid/Blood Leak; Fluid/Blood Leak
EVENT 2: AS REPORTED BY THE USER FACILITY: WHILE THE SET WAS INFUSING TAXOL, LEAKAGE WAS OBSERVED BY THE CLINICIAN. CHEMOTHERAPY WAS CLEANED UP PER FACILITY PROTOCOL. NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8150984 ↗MalfunctionDec 11, 2018Fluid/Blood Leak; Fluid/Blood Leak
EVENT 1: AS REPORTED BY THE USER FACILITY: WHILE THE SET WAS INFUSING TAXOL, LEAKAGE WAS OBSERVED BY THE CLINICIAN. CHEMOTHERAPY WAS CLEANED UP PER FACILITY PROTOCOL. NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8150969 ↗
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page