BD Safety-Lok 309606Recalls & reported problems
Becton, Dickinson And Company · SYRINGE SAFETYLOK 3ML LL · Class 2
All models of BD Safety-Lok (14)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 30382903096061), received between Nov 10, 2017 and Apr 10, 2019 — classified as 21 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (14 reports).
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
- Leak/Splash14
- Detachment of Device or Device Component2
- Fluid/Blood Leak2
- Loose or Intermittent Connection2
- Connection Problem1
- Defective Device1
- Mechanical Problem1
- Positioning Problem1
Patient problems
- No Known Impact Or Consequence To Patient19
- No Consequences Or Impact To Patient1
- No Information1
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 10, 2019Leak/Splash
IT WAS REPORTED THAT BD¿ SAFETY-LOK¿ BD¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP WAS LEAKING. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309606 BATCH NO: UNKNOWN (REPORTED 8266957) IT WAS REPORTED THAT THE SYRINGE WAS LEAKING. SPOKE WITH CUSTOMER ON 03/28 AND IT WAS NOTED THAT THIS WAS DISCOVERED BEFORE USE AND THAT THE EVENT DATE IS NOT KNOW. NO OTHER INFORMATION IS AVAILABLE PER THE CUSTOMER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8499302 ↗MalfunctionMar 29, 2019Leak/Splash
IT WAS REPORTED THAT DURING USE OF THE BD¿ SAFETY-LOK¿ BD¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP THERE IS LEAKAGE OF MEDICATION THE MEDICATION SQUIRTS OUT ALL OVER THE PLACE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8464992 ↗MalfunctionMar 20, 2019Leak/Splash
IT WAS REPORTED THAT BD SAFETY-LOK¿ 3ML SYRINGES, LUER-LOK¿ TIPS LEAKED . THE FOLLOWING WAS REPORTED, "PER EMAIL: PROBLEM: EXPERIENCING LEAKING WHILE USING THESE SYRINGES. PER RESPONSE EMAIL: THE LEAKAGE SEEMS TO BE OCCURRING AT THE LUER LOCK/HUB."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8437100 ↗MalfunctionMar 19, 2019Leak/Splash
IT WAS REPORTED THAT DURING USE OF THE BD¿ SAFETY-LOK¿ BD¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP THAT THE SYRINGES WERE LEAKING. THE LEAKAGE SEEMS TO BE OCCURRING AT THE LUER LOCK/HUB. THERE WERE TWO OCCURRENCES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8433397 ↗MalfunctionMar 19, 2019Leak/Splash
IT WAS REPORTED THAT A BD¿ SYRINGE SAFETYLOK LL WAS LEAKED AT THE LUER LOCK DURING USE. CUSTOMER¿S VERBATIM: ¿ PROBLEM: EXPERIENCING LEAKING WHILE USING THESE SYRINGES. THE LEAKAGE SEEMS TO BE OCCURRING AT THE LUER LOCK/HUB. ¿
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8431906 ↗MalfunctionFeb 18, 2019Leak/Splash
IT WAS REPORTED WITH THE USE OF THE BD¿ SAFETY-LOK¿ BD¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP THERE WAS AN ISSUE WITH 4 SYRINGED LEAKING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8348631 ↗MalfunctionDec 26, 2018Fluid/Blood Leak
IT WAS REPORTED THAT THE BD¿ SAFETY-LOK¿ BD¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP LEAKED FLUID FROM THE NEEDLE HUB.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8197842 ↗MalfunctionDec 26, 2018Leak/Splash
IT WAS REPORTED THAT BD¿ SAFETY-LOK¿ BD¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP LEAKED FLUID FROM THE NEEDLE HUB. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8197634 ↗MalfunctionDec 26, 2018Fluid/Blood Leak
IT WAS REPORTED THAT THE BD¿ SAFETY-LOK¿ BD¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP LEAKED FLUID FROM THE NEEDLE HUB.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8197631 ↗MalfunctionDec 26, 2018Leak/Splash
IT WAS REPORTED THAT BD¿ SAFETY-LOK¿ BD¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP LEAKED FLUID FROM THE NEEDLE HUB. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8197493 ↗MalfunctionDec 19, 2018Leak/Splash
IT WAS REPORTED THAT BD¿ SAFETY-LOK¿ BD¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP LEAKED AT THE HUB DURING USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8180365 ↗MalfunctionDec 19, 2018Leak/Splash
IT WAS REPORTED THERE WAS LEAKAGE AT THE BD¿ SAFETY-LOK¿ BD¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP HUB DURING INJECTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8179273 ↗MalfunctionDec 18, 2018Leak/Splash
IT WAS REPORTED THAT A 3 ML BD¿ SAFETY-LOK¿ BD¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP HAD LEAKAGE AT THE HUB WHEN INJECTING.
Patient problems: No Information
MAUDE report 8174195 ↗MalfunctionOct 22, 2018Leak/Splash; Connection Problem
IT WAS REPORTED THAT BD¿ SAFETY-LOK¿ BD¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP LEAKED AT THE CONNECTION. THERE WERE 5 OCCURRENCES OF THIS EVENT. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7992357 ↗MalfunctionOct 15, 2018Loose or Intermittent Connection; Detachment of Device or Device Component
IT WAS REPORTED THAT BD¿ SAFETY-LOK¿ BD¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP EXHIBITED LOOSE CLOSURE WITH ATTACHED NEEDLE AND NEEDLE DETACHED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7965416 ↗MalfunctionOct 15, 2018Defective Device
IT WAS REPORTED THAT A BD¿ SAFETY-LOK¿ BD¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP HAVE NEEDLES THAT ARE SHOOTING OFF THE SYRINGE WITH A LOT OF FORCE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7965335 ↗MalfunctionOct 15, 2018Loose or Intermittent Connection; Detachment of Device or Device Component
IT WAS REPORTED THAT BD¿ SAFETY-LOK¿ BD¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP EXHIBITED LOOSE CLOSURE WITH ATTACHED NEEDLE AND NEEDLE DETACHED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7965154 ↗MalfunctionOct 11, 2018Mechanical Problem
IT WAS REPORTED THAT BD¿ SAFETY-LOK¿ BD¿ DISPOSABLE SYRINGES WITH BD LUER-LOK¿ TIPS HAD NEEDLES SHOOTING FROM THE SYRINGES WITH A LOT OF FORCE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7957795 ↗MalfunctionAug 6, 2018Leak/Splash
IT WAS REPORTED WITH THE USE OF THE BD¿ SAFETY-LOK¿ BD¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP THERE WAS AN ISSUE WITH LEAKAGE. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7755023 ↗MalfunctionAug 3, 2018Leak/Splash
IT WAS REPORTED THAT 3 ML BD¿ SAFETY-LOK¿ BD¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP LEAKED "FROM THE TOP". REPORTER STATES THAT THE NEEDLE WAS SECURE AND WHEN THE PLUNGER WAS BEING PUSHED DOWN THE MEDICINE STARTED TO LEAK AND NOTHING WAS COMING FROM THE END OF THE NEEDLE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7749334 ↗MalfunctionNov 10, 2017Positioning Problem; Unintended Movement
IT WAS REPORTED THAT A BD 3 ML BD¿ SAFETY-LOK¿ BD¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP WAS FOUND WITH DIFFICULT CONTROL OF PLUNGER MOVEMENT DURING USE. NO REPORT OF INJURY OR MEDICAL INTERVENTION WAS REPORTED
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7018073 ↗
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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