BD Luer-Lok 309569Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00382903095698), received between May 22, 2018 and Jan 20, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2023Disconnection; Leak/Splash; Disconnection; Leak/Splash

  IT WAS REPORTED THAT THE NEEDLE POPPED OFF THE BD¿ SLIP-TIP DISPOSABLE TUBERCULIN SYRINGE DURING THE LOXAPINE INJECTION, LEAKING THE MEDICATION EVERYWHERE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WRITER WENT TO GIVE PATIENT LOXAPINE INJECTION. ONCE PRESSING DOWN TO INJECT MEDICATION THE SYRINGE POPPED OFF OF THE NEEDLE CAUSE MEDICATION TO GO EVERYWHERE. RESULTING IN NOT KNOWING HOW MUCH OF THE MEDICATION THE PATIENT ACTUALLY RECEIVED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16219558 ↗
• MalfunctionJun 7, 2022Material Deformation; Material Deformation

  IT WAS REPORTED WHILE USING BD HYPODERMIC NEEDLE PRECISIONGLIDE¿ 3 ML 22 G DAMAGE TO THE NEEDLE HUB WAS NOTICED DURING USE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE HUB WAS CAUSING AIR ENDER THE HUB INSTEAD OF SUCTION ASSOCIATE NOTICED THE NEEDLE HUB WAS CAUSING AIR ENDER THE HUB INSTEAD OF SUCTION. WAS PREVENTING FROM DRAWING BLOOD PROPERLY AND ADMINISTERING VACCINE. LOT. 1244915 EVENT DATE: (B)(6) 2022. BD NOTIFIED DATE: (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14623547 ↗
• MalfunctionNov 3, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE WITH NEEDLE HAD ISSUES WITH THE NEEDLE SEPARATING FROM THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE NEEDLES ARE NOT STRAIGHT." VIA BD INVESTIGATION: "THE NEEDLE WAS OBSERVED TO BE SEVERELY CROSS THREADED ONTO THE COLLAR OF THE SYRINGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12748835 ↗
• MalfunctionMar 12, 2019Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SYRINGE 3ML LL W/NDL 22X3/4 RB EXPERIENCED BREAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: VERBATIM: ¿SHE ALSO REPORTED A SECOND LOT # 8329966 WHERE THE NEEDLES ARE BREAKING OFF OF THE HUB DURING THEIR USE. SHE DID NOT KNOW HOW MANY EXACTLY (¿A FEW¿), SAID THAT THEY BEEN ¿HAPPENING ON DIFFERENT DAYS¿ BUT DID NOT KNOW THE DATES. SHE DID SAY THAT SHE WILL ADD 3 SAMPLES FROM THIS LOT INTO THE SHIPMENT FOR PR 801931.¿ SEE PR FOR ADDITIONAL DETAILS. COMPLAINT SUMMARY DETAIL: THIS IS MDR REPORTABLE. THE INCIDENT COULD HAVE POTENTIAL TO CAUSE HARM/SERIOUS INJURY. THE INCIDENT COULD HAVE POTENTIAL TO IMPACT MEDICATION DELIVERY. EVENT TYPE: BREAKS DURING USE / MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8411919 ↗
• MalfunctionMar 6, 2019Leak/Splash

  IT WAS REPORTED THAT BD SYRINGE¿ 3ML LL W/NDL 22X3/4 RB LEAKED PAST THE STOPPER WHEN DRAWING UP MEDICATION. NOTICED BEFORE USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8396379 ↗
• MalfunctionOct 31, 2018Break

  IT WAS REPORTED THAT SOME OF THE BD LUER-LOK¿ SYRINGES HAD MISSING/DAMAGED PRECISIONGLIDE¿ NEEDLES. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8025097 ↗
• MalfunctionAug 2, 2018Material Twisted/Bent

  IT WAS REPORTED THAT BD LUER-LOK SYRINGE WITH PRECISIONGLIDE ¿ NEEDLE HAD TWISTED HUBS CAUSING THE NEEDLE TO BEND WHEN USED, THIS COULD LEAD TO POSSIBLE LEAKAGE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7742185 ↗
• MalfunctionJun 14, 2018Detachment Of Device Component; Mechanics Altered

  IT WAS REPORTED THAT 10-15 SYRINGES OF THE BD LUER-LOK SYRINGE PRECISIONGLIDE NEEDLE BD SYRINGE DETACHABLE PRECISIONGLIDE NEEDLE WERE EITHER MISSING FROM PACKAGING, OR WERE BREAKING DURING USE, AND NOT LOCKING INTO THE BARREL. FOUND DURING USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7602408 ↗
• MalfunctionMay 22, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED THERE WAS A "SUBSTANCE" FOUND INSIDE A 3ML BD¿ LUER-LOK¿ SYRINGE WITH NEEDLE. IN ADDITION, THE SUBSTANCE WASN'T NOTICED UNTIL DRAWING UP METHYLPRED WHICH IS MILKY WHITE AND THE SUBSTANCE TURNED IT FROM WHITE TO PINK. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7535434 ↗

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-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-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-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-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-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-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