N/A 302831Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00382903028313), received between Jun 5, 2019 and Aug 6, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50156420 ↗
• MalfunctionMay 6, 2025Break; Break

  MATERIAL: 302831. LOT: UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT INTERNAL PORTION OF SYRINGE BROKE OFF INSIDE EPIDURAL FILTER. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. PRODUCT INFORMATION: PRODUCT CODE: 302831. PRODUCT DESCRIPTION: SYRINGE HYPO 20CC L/S BX/48. LOT/SERIAL #: UNKNOWN. EXPIRY DATE: 2027-01-15. PROBLEM INFORMATION: PRODUCT CONCERN TICKET NUMBER: (B)(4). DATE OF INCIDENT: (B)(6) 2024, CONCERN DESCRIPTION: INTERNAL PORTION OF SYRINGE BROKE OFF INSIDE EPIDURAL FILTER. OCCURRENCES: 1 EA. FOLLOW UP RESPONSE RECEIVED ON 05-MAY-2025. 1) DID THE ISSUE HAPPEN DURING PATIENT USE? IF YES, WAS THERE ANY INJURY? IF SO, PLEASE DESCRIBE AND INCLUDE ANY MEDICAL TREATMENT NEEDED AS A RESULT? R: DURING PATIENT CARE ¿ NO INJURY. 2) COULD YOU CONFIRM WHERE EXACTLY THE DAMAGE OCCURRED, WHETHER LUER PART OR BARREL GOT DAMAGED? R: LUER WAS DAMAGED ¿ BROKE OFF IN HUB OF RECEIVING DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21967456 ↗
• MalfunctionJan 3, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED WHILE USING BD¿ LUER SLIP SYRINGE STERILE, 20 ML THE PLUNGER IS DIFFICULT TO MOVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ALL SYRINGES ARE NEW NOT USED ON PATIENTS. 3) COMPLAINTS ON SYRINGE TIGHTNESS AND NOT SMOOTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16090873 ↗
• MalfunctionApr 27, 2021Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT THE MEDICATION USED WITH THE SYRINGE 20ML LS S/C 48 STRIPPED THE SCALE MARKING INK OFF OF THE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER NEEDS TO KNOW IF THE INK USED ON SYRINGE # (B)(4) IS TOXIC TO HUMANS AS ONE OF THEIR MEDICATIONS IS STRIPPING THE INK OFF THE SYRINGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11731244 ↗
• MalfunctionJun 5, 2019Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT STERILE BREACH OCCURRED WITH A SYRINGE 20ML LS S/C 48. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THAT THE PACKAGING ON SOME OF THE SYRINGES WAS NOT SEALED. VERBATIM: SOMETHING WASN'T SEALED IN OVER HALF OF THE BOX. REPORTER COULD NOT PROVIDE ANY OTHER INFORMATION HE DOESN'T KNOW IF IT WAS THE PACKAGING OR NOT AND COULD NOT PROVIDE THE CUSTOMER'S FIRST AND LAST NAME."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8671686 ↗

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-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-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-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-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