N/A 309654Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00382903096541), received between Jan 5, 2018 and Jul 16, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fungus in Device Environment” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SYRINGE 60ML S/T LATEX FREE CONFIGURE HAD A BENT TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT THE TIP WAS BENT. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12185751 ↗
• MalfunctionApr 13, 2021Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT THE SCALE MARKINGS CAME OFF THE SYRINGE 50ML S/T LATEX FREE CONFIGURE AFTER WASHING AND REUSING IT FOR ABOUT 2 DAYS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PROBLEM WE HAVE IS THAT THE MARKINGS ON THE SYRINGE COME OFF SO FAST. WE HAVE TO REUSE THE SYRINGES BECAUSE OF WHAT INSURANCE WILL ALLOW. MY SON GETS 50ML FLUSHES EVERY 2 HOURS AND WE ONLY WASH THE SYRINGE ABOUT 1 TIME A DAY BUT THE MARKINGS WEAR OFF IN ABOUT 2 DAYS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11655241 ↗
• MalfunctionMar 29, 2021Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT THE SYRINGE 50ML S/T LATEX FREE CONFIGURE HAD NO SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BD 60ML SYRINGE DOES NOT HAVE MEASUREMENT MARKINGS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11586099 ↗
• MalfunctionNov 12, 2019Fungus in Device Environment; Fungus in Device Environment

  MATERIAL NO.: 309654, BATCH NO.: 9133518. IT WAS REPORTED THAT BEFORE USE OF THE BD SYRINGE 60ML S/T LATEX FREE CONFIGURE THERE IS A MOLD-LIKE SUBSTANCE FOUND ON ITEM INSIDE OF PACKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: POSSIBLE MOLD ON ITEM PACKAGE IS WRAPPED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9312218 ↗
• MalfunctionNov 11, 2019Fungus in Device Environment; Fungus in Device Environment

  IT WAS REPORTED THAT PRIOR TO USE MOLD WAS DISCOVERED INSIDE PACKAGING WITH A BD SYRINGE 60ML S/T LATEX FREE CONFIGURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT MOLD WAS INSIDE THE PACKAGING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9304318 ↗
• MalfunctionJan 5, 2018Material Deformation

  IT WAS REPORTED THAT THE SYRINGE TIP OF THE 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE WAS ¿DEFORMED¿, BEFORE USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7169099 ↗

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-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-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-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-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