BD Luer-Lok 309645Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00382903096459), received between Jul 25, 2018 and Aug 14, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Crack” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE BD LUER LOK¿ TIP WITH PRECISIONGLIDE¿ NEEDLE WAS EXPOSED IN THE PACKAGE DUE TO THE BROKEN CAP. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: WHAT IS THE ISSUE YOU EXPERIENCED?: ONE (1) SYRINGE NEEDLE WAS EXPOSED IN THE PACKAGE DUE TO THE BROKEN CAP.

  Patient problems: Needle Stick/Puncture

  MAUDE report 17547215 ↗
• MalfunctionJul 6, 2022Crack; Crack

  IT WAS REPORTED THAT WHILE USING BD 10ML SYRINGE LUER-LOK¿ TIP PRODUCT LEAKED OUT A SPLIT/CRACK ON THE SIDE OF TWO SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DATE: (B)(6) 2022 COMPLAINT NUMBER: (B)(4). ITEM NUMBER: 308-309645 ITEM DESCRIPTION: 10ML LL STER SYRINGE W/ 20GX1.5¿? NDL REG INCIDENT DESCRIPTION: AS PER CS, THIS CUSTOMER ADVISED THAT THE BELOW SYRINGES APPEAR TO HAVE A SPLIT/CRACK IN THE SIDES. WHEN PUSHING MEDICATION THROUGH THE SYRINGE PRODUCT LEAKS OUT THE SIDE. THIS HAS HAPPEN WITH 2 DIFFERENT SYRINGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14940728 ↗
• MalfunctionJul 6, 2022Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED THAT WHILE USING BD 10ML SYRINGE LUER-LOK¿ TIP EXPERIENCED LEAKAGE FROM SPLIT/CRACK ON THE SIDE OF THE TWO SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AS PER CS, THIS CUSTOMER ADVISED THAT THE BELOW SYRINGES APPEAR TO HAVE A SPLIT/CRACK IN THE SIDES. WHEN PUSHING MEDICATION THROUGH THE SYRINGE PRODUCT LEAKS OUT THE SIDE. THIS HAS HAPPEN WITH 2 DIFFERENT SYRINGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14929604 ↗
• MalfunctionJun 16, 2022Missing Information; Missing Information

  IT WAS REPORTED THAT THE BD LUER-LOK 10ML SYRINGE 20 GAUGE X 1 INCH NEEDLE EXPERIENCED 2 MISSING LABELS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE 2 BD PRODUCTS THAT ARE NOT LABELED WITH AN EXPIRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14714514 ↗
• MalfunctionMar 23, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT 10 SYRINGES 10ML LL W/NDL 20X1-1/2 RB EXPERIENCED NO LABEL OR MISSING LABEL INFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309645 BATCH NO.: 5246743. SYRINGES MISSING EXPIRATION DATE AND LOT NUMBERS MISSING NUMBERS/ HARD TO READ.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9868325 ↗
• MalfunctionJul 1, 2019Leak/Splash; Leak/Splash

  MATERIAL NO. 309645 BATCH NO. 9014654 IT WAS REPORTED THAT BEFORE USE OF THE BD LUER-LOK ¿ SYRINGE 5 SYRINGES HAD A CRACKED BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE OPENED 5 SYRINGES THAT ARE CRACKED IN THE PLASTIC PORTION OF THE 10ML SYRINGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8750990 ↗
• MalfunctionJul 25, 2018Missing Information

  IT WAS REPORTED THAT TWO OF THE BD LUER-LOK ¿ SYRINGES WERE FOUND WITHOUT LOT NUMBERS AND EXPIRATION DATES BEFORE USE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7720894 ↗

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-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-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-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-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-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-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-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-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-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