N/A 309656Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 30382903096566), received between Dec 14, 2017 and Nov 4, 2021 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Volume Accuracy Problem” (5 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.

• MalfunctionNov 4, 2021Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED BD CONVENTIONAL SYRINGE HAD MISALIGNED SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MISALIGNED VOLUME MARKINGS AND LABELING ON SYRINGE"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12751914 ↗
• MalfunctionJul 14, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BLOOD "SPURTED" ONTO THE PATIENT DURING USE AFTER INJECTING THEM WITH THE SYRINGE 3ML LS 200 S/C. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AFTER INJECTING A PATIENT, BLOOD SPURTED OUT ON TO THE PATIENT. THERE WAS NO ADDITIONAL MEDICAL ASSISTANCE REQUIRED, THE BLOOD WAS CLEANED UP.".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10269542 ↗
• MalfunctionJun 2, 2020Leak/Splash

  IT WAS REPORTED THAT SYRINGE 3ML LS 200 S/C LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309656 BATCH NO.: UNKNOWN. IT WAS REPORTED THAT THE SYRINGE WOULD NOT FIT THE TRANSFER DEVICE WHICH CAUSED LEAKAGE AT THE LUER CONNECTION. CONCERN DESCRIPTION: REPORTED BY USER THAT THE SLIP TIP DID NOT FIT SECURELY ON THE TRANSFER DEVICE. UPON ATTACHING TRANSFER DEVICE TO SYRINGE AND TRANSFERRING BLOOD TO THE VACUTAINERS, SPECIMEN LEAKED OUT AROUND THE TIP END.

  Patient problems: No Patient Involvement

  MAUDE report 10112558 ↗
• MalfunctionOct 21, 2019Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT BD¿ 3ML SYRINGE SLIP TIP IS MISSING MEASUREMENT LINES. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309656, BATCH NO.: 9002521. IT WAS REPORTED THAT THE SYRINGES ARE MISSING THE MEASUREMENT LINES. VERBATIM: WE JUST HAD ANOTHER CLIENT WANTING TO RETURN SYRINGES FROM THE SAME LOT AND EXPIRY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9213649 ↗
• MalfunctionOct 16, 2019Volume Accuracy Problem; Volume Accuracy Problem

  IT HAS BEEN REPORTED THAT THE SYRINGE 3ML LS 200 S/C HAS BEEN FOUND EXPERIENCING SCALE MARKING ISSUES BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE SYRINGES ARE MISSING THE MEASUREMENT LINES. VERBATIM: I JUST HAD A CLIENT CALL IN THAT HAS A BOX OF SYRINGE BD 3CC LUER SLIP TIP - 200'S THAT ARE MISSING THE MEASUREMENT LINES. LOT # 9002521, EXPIRY DATE 2023/12/31. THIS IS NOT THE FIRST BOX FROM THAT LOT THAT WE HAVE HAD CLIENTS CALL ABOUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9197135 ↗
• MalfunctionOct 8, 2019Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT BEFORE USE, THE SYRINGE 3ML LS 200 S/C WAS OBSERVED WITH MISSING SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1 BOX (309656) MISSING SCALE MARKINGS ON SYRINGES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9167735 ↗
• MalfunctionOct 2, 2019Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT SCALE MARKING ERROR OCCURRED WITH A SYRINGE 3ML LS 200 S/C. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE LINES FOR MEASURING ARE NOT PRINTED ON THE SYRINGES."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9147852 ↗
• MalfunctionApr 26, 2019Leak/Splash

  IT WAS REPORTED THAT CLEAR, OIL-LIKE LIQUID CAME OUT OF THE BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP NEEDLE WHEN PRESSING THE PLUNGER BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SPOUSE REPORTED WHEN HIS WIFE PUSHED ON PLUNGER, CLEAR LIQUID CAME OUT ONTO NEEDLE. STATED CONSISTENCY WAS LIKE "OIL".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8556009 ↗
• MalfunctionDec 14, 2017Crack

  IT WAS REPORTED THAT MEDICATION LEAKED FROM A CRACK IN A BD¿ SLIP TIP STERILE SYRINGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7116883 ↗

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-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-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-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