N/A 301997Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00382903019977), received between May 30, 2018 and Dec 28, 2020 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (9 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 28, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT SYRINGE 10ML LL WWD HAD POOR PERFORATION. THIS OCCURRED ON 27 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 301997, BATCH NO: 8323956.   IT WAS REPORTED THAT EXPERIENCING USAGE DIFFICULTY   EVENT DESCRIPTION STATES: WE HAVE 24 UNCONTAMINATED SYRINGES ON HAND AND THE PROBLEM IS THAT THERE ARE NO DOTTED AREAS TO SEPARATE THEM. AS SCISSORS MUST BE USED TO SEPARATE THEM, THIS COMPROMISES THE STERILIZATION OF THE ITEM.

  Patient problems: No Patient Involvement

  MAUDE report 11083716 ↗
• MalfunctionDec 10, 2020Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT THE SYRINGE 10ML LL WWD BARREL WAS DAMAGED AND THE PLUNGER ROD WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "BEFORE USE, THE CUSTOMER FOUND THAT THE BARREL WAS DAMAGED AND THE PLUNGER ROD WAS BROKEN."

  Patient problems: No Patient Involvement

  MAUDE report 10988662 ↗
• MalfunctionOct 29, 2020Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT SYRINGE 10ML LL WWD WAS DAMAGED, BUT STILL OPERABLE AND THE PLUNGER ROD WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS IS A REPORT ABOUT A DAMAGED SYRINGE. WHEN ASPIRATING SALINE USING THIS SYRINGE, THE HCP FOUND THAT THE BARREL AND PLUNGER ROD WERE DAMAGED/DEFORMED. THE AFFECTED PRODUCT WAS THUS NOT USED. THE CUSTOMER IS ASKING BD TO RETURN THE AFFECTED PRODUCT TO JAPAN AFTER THE COMPLETION OF INVESTIGATION."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10759560 ↗
• MalfunctionSep 26, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SYRINGE 10ML LL WWD PLUNGER ROD WAS DAMAGED. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BEFORE USE, THE CUSTOMER FOUND A DAMAGE ON THE PLUNGER ROD. IT WAS SHARP AND DANGEROUS.

  Patient problems: No Patient Involvement

  MAUDE report 10590948 ↗
• MalfunctionJul 24, 2020Break; Leak/Splash; Volume Accuracy Problem; Break; Leak/Splash; Volume Accuracy Problem

  IT WAS REPORTED THAT 2 SYRINGE 10ML LL WWD EXPERIENCED SCALE MARKING ISSUES, BROKEN/DAMAGED PLUNGER RODS, AND DEVICE DAMAGE/DEFORMATION WHILE STILL CONSIDERED OPERABLE. PRODUCT DEFECTS WERE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRIOR TO USE IN THE MANUFACTURING, DENTED (DAMAGED) BARRELS WERE FOUND.

  Patient problems: No Patient Involvement

  MAUDE report 10321898 ↗
• MalfunctionJul 23, 2020Leak/Splash; Volume Accuracy Problem; Leak/Splash; Volume Accuracy Problem

  IT WAS REPORTED THAT 20 SYRINGE 10ML LL WWD EXPERIENCED A FAILURE TO CONTAIN BLOOD/MEDICATION, BROKEN/DAMAGED PLUNGER RODS, AND SCALE MARKING ISSUES. PRODUCT DEFECT WERE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRIOR TO USE IN THE MANUFACTURING PROCESS, CRACKED (DAMAGED) BARRELS WERE FOUND.

  Patient problems: No Patient Involvement

  MAUDE report 10317914 ↗
• MalfunctionJun 3, 2020Leak/Splash

  IT WAS REPORTED THAT SYRINGE 10ML LL WWD WAS DAMAGED, BUT STILL OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING MFG PROCESS, DENT BARREL PRODUCT WAS CONFIRMED."

  Patient problems: No Patient Involvement

  MAUDE report 10117358 ↗
• MalfunctionJun 3, 2020Volume Accuracy Problem

  IT WAS REPORTED THAT SYRINGE 10ML LL WWD HAD BLURRED SCALE PRINTING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING MFG PROCESS AT TOGO MEDIKIT, BLUR PRINTING PRODUCT WAS CONFIRMED."

  Patient problems: No Patient Involvement

  MAUDE report 10117357 ↗
• MalfunctionJun 2, 2020Leak/Splash

  IT WAS REPORTED THAT SYRINGE 10ML LL WWD PLUNGER ROD WAS DAMAGED. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING MFG PROCESS AT TOGO MEDIKIT, FM ATTACHED PRODUCT WAS CONFIRMED.

  Patient problems: No Patient Involvement

  MAUDE report 10111743 ↗
• MalfunctionJun 2, 2020Leak/Splash

  IT WAS REPORTED THAT 5 SYRINGES 10ML LL WWD WERE FOUND WITH CRACKED PLUNGERS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "DURING MFG PROCESS AT TOGO MEDIKIT, CRACKED PLUNGER PRODUCT WAS CONFIRMED."

  Patient problems: No Patient Involvement

  MAUDE report 10111435 ↗
• MalfunctionFeb 25, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT DURING USE IT WAS DISCOVERED THAT THE PACKAGES HAVE POOR PERFORATION WITH A BD SYRINGE 10ML LL WWD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE SYRINGES ARE NOT PRE-CUT AS USUAL, MAKING IT IMPOSSIBLE TO USE BECAUSE THE PACKAGING TEARS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9751411 ↗
• MalfunctionFeb 20, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THERE WAS NO PERFORATION ON PACKAGING WITH A BD SYRINGE 10ML LL WWD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (1 OF 2 COMPLAINTS) IT WAS REPORTED THAT THERE IS NO DOTTED LINE TO DETACH THE SYRINGES AND THAT THE PROBLEM SEEMS TO AFFECT THE WHILE LOT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9733213 ↗
• MalfunctionFeb 19, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE SYRINGE 10ML LL WWD PACKAGING DID NOT HAVE THE PRECUT PERFORATIONS. THIS WAS FOUND PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: IT WAS REPORTED THAT PACKAGES ARE NOT PRE-CUT. THE HOSPITAL HAS RECEIVED SEVERAL BATCHES LIKE THIS WHICH PREVENTS THE INTEGRITY OF THE ENVELOPE FROM BEING MAINTAINED AND COMPROMISED THE STERILITY OF THE SYRINGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9727975 ↗
• MalfunctionFeb 18, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THERE WAS POOR PERFORATION OF PACKAGE AND STERILITY APPEARED TO BE COMPROMISED WITH A BD SYRINGE 10ML LL WWD. THIS WAS DISCOVERED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (1 OF 2 COMPLAINTS) IT WAS REPORTED THAT PACKAGES ARE NOT PRE-CUT. THE HOSPITAL HAS RECEIVED SEVERAL BATCHES LIKE THIS WHICH PREVENTS THE INTEGRITY OF THE ENVELOPE FROM BEING MAINTAINED AND COMPROMISED THE STERILITY OF THE SYRINGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9720969 ↗
• MalfunctionFeb 11, 2020Leak/Splash; Device Contamination with Chemical or Other Material; Illegible Information; Leak/Splash; Device Contamination with Chemical or Other Material; Illegible Information

  IT WAS REPORTED THAT 2 SYRINGE'S 10ML LL WWD HAD ILLEGIBLE LABEL PRINTING, 1 SYRINGE WAS "DIRTY", 4 SYRINGES HAD DAMAGED BARRELS, AND 1 SYRINGE HAD A DEFECTIVE STOPPER. ALL DEFECTS WERE FOUND BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "BLURRED PRINTING X2, DIRTY X1, DAMAGED X4, STOPPER DEFECT X1."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9694415 ↗
• MalfunctionJan 2, 2020Packaging Problem; Packaging Problem

  IT HAS BEEN REPORTED THAT ONE BD¿ SYRINGE 10ML LL WWD HAS BEEN FOUND EXPERIENCING POOR PERFORATION BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THERE WERE NO DOTTED LINES BETWEEN THE 10CC STERILE SYRINGES RESULTING IN LOSS OF TIME BECAUSE IT REQUIRES SCISSORS TO SEPARATE THEM.

  Patient problems: No Patient Involvement

  MAUDE report 9540438 ↗
• MalfunctionDec 27, 2019Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT A PACKING ERROR OCCURRED BEFORE USE WITH A SYRINGE 10ML LL WWD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE PACKAGES ARE NOT SEPARABLE. THE PACK OF 5 SYRINGES CANNOT BE SEPARATED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9527661 ↗
• MalfunctionDec 20, 2019Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT BEFORE USE, IT WAS NOTICED THAT THERE WAS NO PACKAGING PERFORATION ON THE SYRINGE 10ML LL WWD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NORMALLY, THESE SYRINGES COME IN A PACKAGE OF 5 DETACHABLE SYRINGES AND THIS LOT NUMBER ARE NOT.".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9504721 ↗
• MalfunctionDec 18, 2018Break

  IT WAS REPORTED THAT THE BD LUER-LOK¿ TIP SYRINGE PLUNGER AND BARREL WERE DAMAGED.

  Patient problems: No Information

  MAUDE report 8175080 ↗
• MalfunctionMay 30, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT BROWN FOREIGN MATTER WAS FOUND EMBEDDED IN A 10ML BD SYRINGE LUER-LOK TIP PRIOR TO USE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7554535 ↗

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-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-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-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-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