Filter Needle 415030Recalls & reported problems
B. Braun Medical Inc. · Filter Needle (FN5119) · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04022495285799), received between Aug 22, 2018 and Oct 9, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (5 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Contamination /Decontamination Problem5
Patient problems
- No Patient Involvement3
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 9, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED, DROPLETS WERE FOUND INSIDE THE PRODUCT BEFORE PACKAGE OPEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20412624 ↗MalfunctionJul 8, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE B. BRAUN GLOBAL AFFILIATE: WHEN DID THE FAILURE OCCUR: BEFORE APPLICATION. REASON OF COMPLAINT: DROPLETS WERE FOUND INSIDE THE PRODUCT BEFORE PACKAGE OPEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19688696 ↗MalfunctionAug 22, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 3: "WE HAVE RECENTLY FOUND THAT SOME OF OUR NEEDLES THAT WE ARE USING FOR COMPOUNDING HAVE GOT A FLUID RESIDUE ON THE TIP OF THE NEEDLE THAT'S SEALED IN A PACK." NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 7806544 ↗MalfunctionAug 22, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 2: "WE HAVE RECENTLY FOUND THAT SOME OF OUR NEEDLES THAT WE ARE USING FOR COMPOUNDING HAVE GOT A FLUID RESIDUE ON THE TIP OF THE NEEDLE THAT'S SEALED IN A PACK." NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 7806539 ↗MalfunctionAug 22, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 1: "WE HAVE RECENTLY FOUND THAT SOME OF OUR NEEDLES THAT WE ARE USING FOR COMPOUNDING HAVE GOT A FLUID RESIDUE ON THE TIP OF THE NEEDLE THAT'S SEALED IN A PACK." NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 7806077 ↗
Other NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE devices
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- N/A 305200Becton, Dickinson And Company · NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE99 reports
- PneumoDart TM-317TyTek Medical Inc. · Needle, Aspiration And Injection, Disposable1 recall1 report
- TPAK TM-303TyTek Medical Inc. · Needle, Aspiration And Injection, Disposable1 recall0 reports
- N/A 305181Becton, Dickinson And Company · NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE32 reports
- SOL-M™ Blunt Fill Needle with 5 Micron Filter 110022Sol-Millennium Medical, Inc. · Needle, Aspiration And Injection, Disposable17 reports
- CONFIDENCE SPINAL CEMENT SYSTEM 283903611Medos International Sàrl · NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE17 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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