BD Luer-Lok 309633Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00382903096336), received between Jan 8, 2021 and Jun 11, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

10 other recalls cover devices cleared under the same FDA submission (K110771); 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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2024Defective Device; Defective Device

  MATERIAL: 309633, BATCH#: 3017600. IT WAS REPORTED THAT THE BD SYRINGE 5ML LL W/NDL 21X1-1/2 RB NEEDLE HUB HAD A HOLE, WAS CRACKED / DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I DON'T REALLY WANT TO REGISTER WITH YOU, I JUST WANT TO FILE A PRODUCT. YOUR 5ML SYRINGES WITH THE GREEN NEEDLES, PRODUCT NUMBER 309633 ARE BEING PRODUCED WITH A FLAW IN THE NEEDLES HUB WHICH CAUSE THEM TO LEAK. IT APPERS TO BE A HOLE. THIS PROBLEM HAS BEEN ON-GOING SINCE YOU STOPPED PRODUCING THE 5ML SYRINGE IN THE YELLOW WRAPPER. YES, SEVERAL LOTS WITH THIS FLAW HAVE LEFT YOUR PRODUCTION FACILITY. OUR CURRENT LOT IS 3017600. I COMPOUND HAZARDOUS DRUGS AND I AM TIRED OF GETTING A SHOWER OF DEATH EVERY 1000 SYRINGES, AND I KNOW OTHERS ARE TIRED OF IT AS WELL. I THOUGHT THAT I WOULD FILE A PRODUCT COMPLAINT DIRECTLY WITH YOU. FOR SOME REASON YOU HAVE DECIDED TO MAKE THIS DIFFICULT TO DO, WHICH IS ALARMING BECAUSE PRODUCT COMPLAINT REPORTING IS A REQUIREMENT OF LAW. I REALLY DON'T WANT TO HAVE TO COMPLETE FORM FDA 3500 MYSELF. CAN YOU ASSURE ME THAT THIS EMAIL WILL GET TO THE CORRECT QA PERSON WITHIN YOUR COMPANY.". ITEM # 309633. LOT # 3017600. ADDITIONAL INFORMATION PROVIDED: 1

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19515734 ↗
• InjuryOct 12, 2023Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: Eye Irritation; Numbness

  MAUDE report 17924814 ↗
• MalfunctionJan 15, 2021Break

  IT WAS REPORTED THAT 2 SYRINGES 5ML LL W/NDL 21X1-1/2 RB EXPERIENCED A BROKEN NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:309633, BATCH NO:0224356. CUSTOMER E-MAILED A PHOTO OF TWO BROKEN NEEDLES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11181371 ↗
• MalfunctionJan 8, 2021Break; Break

  IT WAS REPORTED THAT SYRINGE 5ML LL W/NDL 21X1-1/2 RB NEEDLE BREAKS OFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309633 BATCH NO.: 0224356. IT WAS REPORTED THAT NEEDLES ARE BREAKING OFF DURING DRAWING MEDICATION.

  Patient problems: No Patient Involvement

  MAUDE report 11141095 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110771. One submission often covers many models, so check the product and lot details in each record.

• Z-2614-2026 · Apr 28, 2026 · Open, Classified
  SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston
• Z-2749-2017 · Sep 16, 2016 · Terminated
  BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 23G x 1 (0.6mm x 25mm) Catalog #309571 The BD Single Use, Hypodermic Syringe is intended for use by health care professi
• Z-2751-2017 · Sep 16, 2016 · Terminated
  BD 3ml Syringe Luer-Lok" Tip Catalog 309657 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
• Z-2752-2017 · Sep 16, 2016 · Terminated
  BD 10mL Syringe Luer-Lok Tip Catalog number 301997 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injec
• Z-2747-2017 · Sep 16, 2016 · Terminated
  BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #305062
• Z-2750-2017 · Sep 16, 2016 · Terminated
  BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #309580 The BD Single Use, Hypodermic Syringe is intended for use by health care prof
• Z-2753-2017 · Sep 16, 2016 · Terminated
  BD 3ml Syringer Luer-Lok Tip Catalog #309604 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
• Z-1936-2016 · Mar 25, 2016 · Terminated
  Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection
• Z-1937-2016 · Mar 25, 2016 · Terminated
  Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection
• Z-1055-2015 · Dec 19, 2014 · Terminated
  BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection ; Catalog #303348, BD 10 mL Syringe Luer-Lok Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 4