NORM-JECT® NJ-4606205-02Recalls & reported problems
B. Braun Medical Inc. · NORM-JECT 20 ML BBRAUN AIR-TITE · Class 2
All models of NORM-JECT (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046955597093), received between Sep 21, 2020 and Sep 21, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (3 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
- Contamination /Decontamination Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 1: FIBER-LIKE PARTICLES WERE IDENTIFIED IN A FINISHED PRODUCT MANUFACTURED UTILIZING THIS SYRINGE AS AN IN-PROCESS COMPONENT. THE PARTICLES APPEAR TO BE NATURAL/CELLULOSE TEXTILES, EITHER BLUE OR BLUE-BLACK IN COLOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10560785 ↗MalfunctionSep 21, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 3: FIBER-LIKE PARTICLES WERE IDENTIFIED IN A FINISHED PRODUCT MANUFACTURED UTILIZING THIS SYRINGE AS AN IN-PROCESS COMPONENT. THE PARTICLES APPEAR TO BE NATURAL/CELLULOSE TEXTILES, EITHER BLUE OR BLUE-BLACK IN COLOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10560781 ↗MalfunctionSep 21, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 2: FIBER-LIKE PARTICLES WERE IDENTIFIED IN A FINISHED PRODUCT MANUFACTURED UTILIZING THIS SYRINGE AS AN IN-PROCESS COMPONENT. THE PARTICLES APPEAR TO BE NATURAL/CELLULOSE TEXTILES, EITHER BLUE OR BLUE-BLACK IN COLOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10560776 ↗
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- BD Plastipak Syringe 300865Becton, Dickinson And Company · Syringe, piston515 reports
- N/A 302830Becton, Dickinson And Company · Syringe, piston462 reports
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- BD Ultra-Fine 328468Becton, Dickinson and Company Inc · Syringe, piston323 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.
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