N/A 302891Recalls & reported problems
Becton, Dickinson And Company · NEEDLE 27GA 7/8IN ECG BLT · Class 2
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 50382903028912), received between Nov 20, 2018 and Aug 5, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Contamination” (2 reports).
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
- Contamination2
- Device Contamination with Chemical or Other Material2
- Contamination /Decontamination Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 5, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50142548 ↗MalfunctionMay 8, 2026Contamination
IT IS REPORTED, FOREIGN MATTER. ADDITIONAL INFORMATION: WE FOUND THIS ISSUE ON APRIL 21 , 2026, DURING OUR INCOMING INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25123105 ↗MalfunctionSep 8, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE NEEDLE 27GA 7/8IN ECG BLT HAD A LOOSE, BLACK THREAD ON IT DURING SURGERY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING A SURGERY THE CANNULA LOOSE A FOREIGN BODY (BLACK THREAD SHAPE)."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12442966 ↗MalfunctionNov 12, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT IS REPORTED THAT THERE WAS A MIX OF PRODUCT, FOREIGN MATTER ON DEVICE, AND 7 OCCASIONS OF DOUBLE NEEDLES WITH A BD NEEDLE 27GA 7/8IN. THIS WAS DISCOVERED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED A NEEDLE WAS FOUND WITH AN ORANGE HUB, A NEEDLE WAS FOUND WITH AN UNKNOWN PART ON TOP, AND 7 NEEDLES WERE FOUND WITH A DOUBLE NEEDLE. ADDITIONAL INFORMATION RECEIVED BY CUSTOMER: INSIDE BAG AN ORANGE HUB WAS FOUND( PART ON RIGHT SIDE) INSIDE BAG A GRAY CANNULA RECEIVED WITH AN UNKNOWN PART ON TOP (PART ON LEFT), DOUBLE NEEDLE ASSEMBLE INTO CANNULA. A TOTAL OF 7 PIECES 7 WERE REPORTED BUT ON 4 SAMPLES WITH THE EXTRA NEEDLE FALL OFF AND SECOND NEEDLE WAS NOT RECOVERED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9310771 ↗MalfunctionNov 20, 2018Contamination /Decontamination Problem
IT WAS REPORTED THAT BD NEEDLE 27GA 7/8IN ECG BLT HAD FOREIGN MATTER ON THE NEEDLE BEFORE USE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8092246 ↗
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
Other Needle, hypodermic, single lumen devices
- BD Nano 2nd Gen 320550Becton Dickinson Pen Limited · Needle, hypodermic, single lumen2,044 reports
- BD SafetyGlide 305916Becton, Dickinson And Company · Needle, hypodermic, single lumen1,767 reports
- BD Nano Ultra-Fine 320122Becton Dickinson Pen Limited · Needle, hypodermic, single lumen601 reports
- N/A 305106Becton, Dickinson And Company · Needle, hypodermic, single lumen1 recall467 reports
- N/A 305110Becton, Dickinson And Company · Needle, hypodermic, single lumen418 reports
- BD Safe-Clip 328235Becton, Dickinson and Company Inc · Needle, hypodermic, single lumen268 reports
- BD Ultra-Fine 320109Becton Dickinson Pen Limited · Needle, hypodermic, single lumen229 reports
- BD AutoShield Duo 329515Becton, Dickinson And Company · Needle, hypodermic, single lumen208 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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