N/A 309623Recalls & reported problems
Becton, Dickinson And Company · SYRINGE 1ML S/T W/NDL 27X1/2 RB · Class 2
Quick summary
This BD syringe with an attached needle is used to draw up and inject medicine. Many of the 180 reports describe liquid leaking, the needle coming off or pulling out, and parts breaking. The reports include 5 injuries, 175 malfunctions and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 179
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 179 adverse event reports that list this exact device (DI 00382903096237), received between Mar 20, 2018 and Sep 18, 2026 — classified as 5 injuries, 174 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (43 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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash43
- Connection Problem38
- Break19
- Detachment of Device or Device Component19
- Complete Blockage7
- Separation Failure7
- Contamination /Decontamination Problem6
- Material Separation6
Patient problems
- No Clinical Signs, Symptoms or Conditions123
- No Known Impact Or Consequence To Patient24
- No Consequences Or Impact To Patient9
- Needle Stick/Puncture8
- Insufficient Information6
- Hyperglycemia3
- No Patient Involvement3
- Bruise/Contusion1
Recent adverse event reports
The 25 most recent of 179 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Detachment of Device or Device Component
Patient problems: Insufficient Information
MAUDE report 50823231 ↗MalfunctionSep 18, 2026Detachment of Device or Device Component
It was reported that BD SYRINGE 1ML S/T W/NDL 27X1/2 RB needle pulled out of hub.Complaint via Email. Awareness Date: 25Aug2026.BD 30 day Due Date: 27Sep2026.Product: GATTEX 5MG PATIENT KIT 30CT (GATTEX 5MG PATIENT KIT 30CT).Lot: AV26098AA. Component: Description: Syringe 1mL S/t w/NDL 27x1/2 RB.BD Product No: 309623.BD Lot: 6007437 & 6047370. Complaint Description:Patient's sister reported that sometimes the needle is not tight. Sometimes it breaks off in the patient's arm when it injects too slowly. Medication comes out slowly from the syringe. No further pertinent details provided.Country of Origin: Sample / Photo Availability:None. Follow up performed with no reply. Adverse Event (AE): 2026TUS108180. Patient Identifiers:Patient identifiers (e.g., gender, weight, ethnicity) will not be available for this investigation request. Additional Information:No additional information is available at this time. Prior Investigation Reference / Assessment:No prior investigation.
Patient problems: Insufficient Information
MAUDE report 50823211 ↗MalfunctionSep 16, 2026Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793760 ↗MalfunctionApr 28, 2026Contamination
IT WAS REPORTED THAT BD SYRINGE 1ML S/T W/NDL 27X1/2 RB HAD EPOXY ON NEEDLE. COMPLAINT VIA EMAIL. CONTACT NAME: XXXXX, CONTACT NUMBER: XXXX, CONTACT EMAIL IF NO EMAIL N/A: XXXXX, ITEM(S): 309623, LOT(S): 5204367, DATE INCIDENT OCCURED MM/DD/YYYY: ON (B)(6) 2026, TOTAL NUMBER OF OCCURANCES: 3, WAS THE PATIENT IMPACTED? GLUE ON OUTSIDE OF NEEDLE, IF YES PLEASE DESCRIBE: CAUSES EXCESSIVE BLEEDING. WAS ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO A HEALTHCARE PROFESSIONAL? NO. IF YES PROVIDE DETAILS: IS A SAMPLE AVAILABLE? YES. IF YES PLEASE PROVIDE ADDRESS WHERE TO SEND THE RETURN LABEL: X.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25018602 ↗MalfunctionApr 27, 2026Contamination /Decontamination Problem
IT WAS REPORTED THAT BD SYRINGE 1ML S/T W/NDL 27X1/2 RB CONTAINED FOREIGN MATTER. COMPLAINT VIA EMAIL. RECENTLY, I NOTICED AFTER INJECTING MY MEDICATION HE WOULD HURT MORE AND BLEED SLIGHTLY, WHICH WAS UNUSUAL. I STARTED LOOKING AT THE SYRINGES BEFORE I INJECT IT AND SO FAR, I HAVE HAD THREE WITH A LITTLE WHITE PUMP ON THE NEEDLE. AT FIRST, I THOUGHT IT MAY BE AN ISOLATED INCIDENT, BUT ONCE I HIT THREE, I BROUGHT IT TO THE PHARMACY AND THEY TOLD ME TO CONTACT YOU. MY MAIN CONCERN IS IF MATERIAL COULD BREAK OFF AND GET INTO MINE OR SOMEONE ELSE¿S BLOOD SCREENING IF YOU NEED TO CONTACT ME MY DIRECT PHONE NUMBER IS X.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25009989 ↗MalfunctionApr 22, 2026Connection Problem
IT WAS REPORTED THAT BD SYRINGE 1ML S/T W/NDL 27X1/2 RB HAD A SYRINGE NEEDLE CONNECTIVITY ISSUE. VERBATIM: COMPLAINT VIA EMAIL. COMPLAINT: A REGISTERED NURSE REPORTED TO (B)(6) MEDICAL CARE VIA EMAIL THAT A BD 1ML TB SYRINGE SLIP TIP WITH BD PRECISION GLIDE NEEDLE DETACHED FROM SYRINGE WHEN USED FOR INTRADERMAL INJECTION LEAVING NEEDLE ON PATIENT'S SKIN. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Patient problems: Insufficient Information
MAUDE report 24955261 ↗MalfunctionApr 13, 2026Break
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24862912 ↗MalfunctionApr 2, 2026Contamination /Decontamination Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24767649 ↗MalfunctionApr 2, 2026Contamination /Decontamination Problem
IT WAS REPORTED THAT BD SYRINGE 1ML S/T W/NDL 27X1/2 RB - 309623 CONTAINED FOREIGN MATTER. COMPLAINT VIA EMAIL. TAKEDA AWARENESS DATE: 13 MAR 2026. PRODUCT: GATTEX 5 MG PATIENT KIT, 30-COUNT. TAKEDA LOT: COMPONENT: BD DOSING SYRINGE. DESCRIPTION: SYRINGE 1 ML, STERILE, WITH NEEDLE 27G X 1/2" RB, BD PRODUCT NO.: 309623, BD LOT#: 5106625 & 5106626. COMPLAINT DESCRIPTION: THE PATIENT REPORTED THAT HE WAS ONE VIAL THAT HE WAS UNABLE TO USE. THE PATIENT STATED THAT WHEN HE WENT TO PUSH THE AIR OUT OF SYRINGE BEFORE INJECTING IT AND A WHITE DROP/ PARTICLE CAME OUT AND HE DIDN'T FEEL COMFORTABLE USING IT BASED ON WHAT THE TRAINER TOLD HIM. THE PATIENT STATED THAT HE FOLLOWED ALL THE MIXING DIRECTIONS HE WAS GIVEN. NO DOSE WAS MISSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24767647 ↗MalfunctionMar 30, 2026Connection Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24716517 ↗MalfunctionMar 25, 2026Connection Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24689510 ↗MalfunctionMar 25, 2026Connection Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24689495 ↗MalfunctionMar 17, 2026Break
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24617514 ↗MalfunctionMar 16, 2026Break
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24611606 ↗MalfunctionMar 13, 2026Break; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24594101 ↗MalfunctionFeb 11, 2026Break
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24315990 ↗MalfunctionJan 16, 2026Connection Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24101591 ↗MalfunctionJan 16, 2026Connection Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24101590 ↗MalfunctionDec 16, 2025Break; Break
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23815441 ↗MalfunctionDec 16, 2025Break; Break
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23815437 ↗MalfunctionDec 3, 2025Connection Problem; Connection Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23710747 ↗MalfunctionNov 17, 2025Connection Problem; Connection Problem
IT WAS REPORTED THAT THE BD SYRINGE 1ML S/T W/NDL 27X1/2 RB HAD A SYRINGE NEEDLE CONNECTIVITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #309623. BATCH #4303339. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CONTACT NAME: CONTACT NUMBER: CONTACT EMAIL (IF AVAILABLE): N/A. ITEM(S): 309623. LOT(S):4303339. DATE INCIDENT OCCURRED: ON GOING. WAS THE PATIENT IMPACTED? YES. IF YES, DESCRIBE: WHEN TAKING CAP OFF NEEDLE COMES APART IS A SAMPLE AVAILABLE? YES. CUSTOMER REQUEST? REPLACEMENT. ADDITIONAL INFORMATION PROVIDED: CUSTOMER SAID THAT THE NEEDLE HUB IS COMING LOOSE AND DISCONNECTING FROM THE SYRINGE CUSTOMER ALSO SAID THAT HER DR HAD MENTIONED OTHER PTS HAVING THE SAME ISSUE, I CALLED THE OFFICE AND SPOKE WITH A CLINICIAN WHO SAID THEY WERE GOING TO CONFIRM IF THIS IS IN FACT TRUE. SHE WILL BE EMAILING US BACK WITH THIS PR IN THE SUBJECT. 610-366-1366. DR (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23577477 ↗MalfunctionOct 27, 2025Connection Problem; Connection Problem
IT WAS REPORTED THAT THE BD SYRINGE 1ML S/T W/NDL 27X1/2 RB HAD A SYRINGE NEEDLE CONNECTIVITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 309623, BATCH#: 4303341. RCC RECEIVED A COMPLAINT VIA PHONE. CUSTOMER STATES THAT THEIR CASE OF SYRINGES DO NOT OPEN OR CLOSE. THEY ORDERED OFF OF PO: (B)(4). CUSTOMER IS UNSURE IF THEIR CUSTOMER HAS ANY PRODUCT TO RETURN FOR INVESTIGATION. REF#: 309623. LOT#: UNKNOWN AT THE TIME OF THE CALL. CUSTOMER RESPONSE RECEIVED ON 10-OCT-2025. 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? WE NOTICED THIS ISSUE LAST WEEK, WHERE THE NEEDLES ATTACHED TO THESE SYRINGES DO NOT ATTACH PROPERLY/COMPLETELY AND THAT MEANS THE SYSTEM IS OVERPRESSURIZED/WHEN EXPELLING LIQUIDS THE NEEDLES HAVE A TENDENCY TO COME OFF¿EVEN WHEN THEY ARE REMOVED AND THE AIR IN THE NEEDLE IS EXPRESSED BEFOREHAND. WE NOTICED THIS ISSUE ON 29/09/2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23392309 ↗MalfunctionOct 3, 2025Break; Break
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23214379 ↗MalfunctionOct 3, 2025Break; Break
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23214378 ↗
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, ClassifiedSYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston
- Z-2750-2017 · Sep 16, 2016 · TerminatedBD 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 · TerminatedBD 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 · TerminatedBD 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-2753-2017 · Sep 16, 2016 · TerminatedBD 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-2749-2017 · Sep 16, 2016 · TerminatedBD 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-2752-2017 · Sep 16, 2016 · TerminatedBD 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-1937-2016 · Mar 25, 2016 · TerminatedHenry 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 · TerminatedHenry 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 · TerminatedBD 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
Other Syringe, piston devices
- BD Luer-Lok 309657Becton, Dickinson And Company · Syringe, piston1,266 reports
- BD Luer-Lok 309653Becton, Dickinson And Company · Syringe, piston948 reports
- BD Luer-Lok 309628Becton, Dickinson And Company · Syringe, piston862 reports
- N/A 302995Becton, Dickinson And Company · Syringe, piston1 recall537 reports
- BD Plastipak Syringe 300865Becton, Dickinson And Company · Syringe, piston515 reports
- N/A 302830Becton, Dickinson And Company · Syringe, piston462 reports
- N/A 302832Becton, Dickinson And Company · Syringe, piston424 reports
- BD Ultra-Fine 328468Becton, Dickinson and Company Inc · Syringe, piston323 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.