BD Safety-Lok 305564Recalls & reported problems
Becton, Dickinson And Company · SYR SAFETYLOK 10ML LL W/NDL 21X1-1/2 TW · Class 2
All models of BD Safety-Lok (14)
Data updated Oct 18, 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 30382903055648), received between Jan 29, 2019 and Feb 21, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
1 other recall cover devices cleared under the same FDA submission (K944757); 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 18, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak1
- Leak/Splash1
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 21, 2019Leak/Splash
IT WAS REPORTED THAT THE SYR SAFETYLOK 10ML LL W/NDL 21X1-1/2 TW EXPERIENCED LEAKAGE AROUND THE PLUNGER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8358989 ↗MalfunctionJan 29, 2019Fluid/Blood Leak
WHEN UTILIZING THE 10ML SYRINGE TO INJECT MEDICATION THE MEDICATION LEAKED AROUND THE PLUNGER, OUT OF THE SYRINGE, AND ONTO THE PATIENT. THIS PATIENT WAS NOT NEGATIVELY IMPACTED AND UNFORTUNATELY, THE DEVICE WAS NOT RETAINED. IT IS NOT KNOWN WHAT MEDICATION WAS BEING ADMINISTERED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8284524 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K944757. One submission often covers many models, so check the product and lot details in each record.
- Z-2008-2019 · Feb 1, 2019 · Terminated3mL Safety-Lok Syringe, Catalog Number 309606, UDI 30382903096061
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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