BD Nokor 305215Recalls & reported problems
Becton, Dickinson And Company · NEEDLE ADMIX NOKOR 18X1-1/2 TW · Class 1
All models of BD Nokor (5)
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 00382903052158), received between Feb 1, 2019 and Nov 9, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).
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 Problem1
- Device Contamination with Chemical or Other Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 9, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
MATERIAL#: 305215. BATCH#: 2363728. IT WAS REPORTED BY THE CUSTOMER THAT "AFTER USING THIS NEEDLE TO INTRODUCE PARTICULATE FREE WATER INTO THEIR VIAL THROUGH THE STOPPER, WE OBSERVED PARTICULATE FLOATING IN THE VIAL. THAT PARTICULATE WAS IDENTIFIED AS ACRYLIC POLYMER. THE CLIENT HAS REQUESTED I REACH OUT TO BD TO DETERMINE RULE OUT THIS NEEDLE AS A POTENTIAL ROOT CAUSE FOR THIS CONTAMINATION." RESPONSE RECEIVED ON 09-NOV-2023. CAN YOU PLEASE PROVIDE THE LOT NUMBER OF THE AFFECTED PRODUCT? LOT 2363728 IS THERE SAMPLE AVAILABLE TO RETURN FOR FURTHER EVALUATION? WE CAN SHIP SAMPLES. NEED TO KNOW QUANTITY AND SHIPPING INFORMATION. IF NO, CAN A PHOTO BE PROVIDED? WHAT DID THE FM LOOK LIKE? (COLOR / SIZE, LIQUID LIKE OR POWDER LIKE)? SEE PICTURES BELOW. RESPONSE RECEIVED ON 14-NOV-2023. BD TEAM, SEE PICTURE OF MATERIAL TO CONFIRM PART NUMBER AND LOT. I WILL WORK TO GET THIS MATERIAL SHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18100181 ↗MalfunctionFeb 1, 2019Contamination /Decontamination Problem
IT WAS REPORTED THAT BD¿ NEEDLE ADMIX NOKOR 18X1-1/2 TW HAD AN INSECT INSIDE THE NEEDLE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8299039 ↗
Other NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE devices
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- N/A 305180Becton, Dickinson And Company · NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE300 reports
- N/A 305200Becton, Dickinson And Company · NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE99 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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