BD Syringe 303344Recalls & reported problems
Becton, Dickinson And Company · SYRINGE 1ML S/T W/NDL 27X3/8 IB · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00382903033447), received between Feb 26, 2025 and Oct 15, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Connection Problem” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K021475); they may or may not involve this specific model.
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
- Connection Problem1
- Material Perforation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2025Material Perforation; Material Perforation
IT WAS REPORTED THAT THE BD SYRINGE 1ML S/T W/NDL 27X3/8 IB NEEDLE WENT THROUGH THE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 303344, BATCH#: 3117445. RCC RECEIVED A COMPLAINT VIA EMAIL. TWO DIFFERENT 1ML (27G) TB SYRINGES WERE DEFECTIVE IN THE SAME LOT. ONE SYRINGE, HAD THE NEEDLE BENT AND WAS COMPLETELY EXPOSED OUTSIDE THE CAP (THE NEEDLE WENT THROUGH THE SIDE OF THE CAP) IN THE SECURED PACKAGE. THE OTHER SYRINGE HAD THE NEEDLE SLIGHTLY BENT (IT DID NOT PIERCE THE CAP) HOWEVER, THE ACTUAL CAP WAS BROKEN AND DIDN'T FIT SECURELY OVER THE NEEDLE. THE SYRINGES WERE NEVER EXPOSED TO THE PATIENT - THE DEFECTS WERE IDENTIFIED BEFORE PT CONTACT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23285887 ↗MalfunctionFeb 26, 2025Connection Problem; Connection Problem
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21469050 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K021475. One submission often covers many models, so check the product and lot details in each record.
- Z-0588-2021 · Nov 18, 2020 · TerminatedBD PrecisionGlide Needle 30G x 1/2 (0.3 mm X 13mm) REF 305106 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampoules and parts of the bo
- Z-0207-2018 · May 31, 2017 · TerminatedBD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain bl
- Z-1009-2012 · Oct 8, 2011 · TerminatedBD 30G1/2" Precision Glide" Needle Needles are used for aspiration and injection of medications
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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