N/A 305194Recalls & reported problems
Becton, Dickinson And Company · NEEDLE 23X1-1/2 RB TW · Class 2
Quick summary
This Becton Dickinson hypodermic needle is used for injections, including drawing up diluent for drugs such as Gattex. Most of the 34 reports describe needles that were blocked or wouldn't flow, leaked or splashed fluid when attached to a syringe, or broke, with a few noting a plastic fragment found inside the needle. One injury was reported 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
- 38
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00382903051946), received between Oct 11, 2018 and Sep 29, 2026 — classified as 1 injury, 37 malfunctions.
The most frequently reported specific device problem is “Complete Blockage” (12 reports).
3 other recalls cover devices cleared under the same FDA submission (K021475); 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
- Complete Blockage12
- Leak/Splash9
- Break3
- Device Contamination with Chemical or Other Material3
- Material Separation3
- Contamination2
- Device Markings/Labelling Problem2
- Unintended Ejection2
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- Insufficient Information7
- No Known Impact Or Consequence To Patient4
- Device Embedded In Tissue or Plaque1
- Ecchymosis1
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Leak/Splash
Patient problems: Insufficient Information
MAUDE report 50934064 ↗MalfunctionSep 29, 2026Leak/Splash
Patient problems: Insufficient Information
MAUDE report 50934063 ↗MalfunctionSep 3, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50589670 ↗MalfunctionSep 3, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50589669 ↗MalfunctionAug 27, 2026Leak/Splash; Adverse Event Without Identified Device or Use Problem
It was reported, NEEDLE 23X1-1/2 RB TW, leaking occurred as a result of difficulty with getting the cap off.The following was provided by the initial reporter: Patient reports "I was having difficulty removing the needle cap from the mixing needle and some of the fluid pushed out so there wasn't enough diluent in the Gattex vial. I think I hit a vein when I gave my injection once because there is a bruise that is still present. I have high anxiety, so I have to take some deep breaths." (b)(6)2026 MS spoke with Pt on phone. Sample discarded and pt used another syringe. No pictures available. Pt did not miss dose. Pt confirmed that the leaking occurred as a result of difficulty with getting the cap off. AE: Bruising at injection site.
Patient problems: Ecchymosis; No Clinical Signs, Symptoms or Conditions
MAUDE report 50483960 ↗MalfunctionMar 30, 2026Leak/Splash
IT WAS REPORTED, ONCE THEY ATTACH THE NEEDLE, AND TRIES TO PUSH DILUENT LIQUID INTO POWDER VIAL, IT WILL SQUIRT OUT THE SIDE OR LEAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24731130 ↗MalfunctionJan 29, 2026Contamination
IT IS REPORTED FOREIGN MATTER. DESCRIPTION: DURING USE, WATER WOULD NOT FLOW THROUGH THE NEEDLE. UPON REMOVAL AND INSPECTION, A PIECE OF PLASTIC WAS FOUND OBSTRUCTING THE LUMEN. ADDITIONAL INFORMATION: ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS: NO. TOTAL NUMBER OF OCCURRENCES: 1.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24209951 ↗MalfunctionJul 7, 2025Defective Component; Defective Component
IT WAS REPORTED NEEDLE/SYRINGE DID NOT HAVE A HOLE AND WAS UNABLE TO PUNCTURE THE STERILE WATER. COMPLAINT DESCRIPTION: MATERIAL # 305194 BATCH # 3347792 PATIENT REPORTS THAT SHE HAD A DEFECTIVE SUPPLY (STERILE WATER AND NEEDLE/SYRINGE) IN THE GATTEX ANCILLARY SUPPLY KIT. PATIENT SAID THE NEEDLE/SYRINGE DID NOT HAVE A HOLE AND WAS UNABLE TO PUNCTURE THE STERILE WATER. PATIENT USED TWO STERILE WATER VIALS WHICH ENDED UP LEAKING AND ALSO NEED REPLACED. UNKNOWN IF PATIENT EXPERIENCED AN ADVERSE EVENT OR IF DEFECTIVE DEVICE IS STILL ON HAND. AE: NO AE REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22420638 ↗MalfunctionApr 16, 2025Connection Problem; Connection Problem
MATERIAL #305194 LOT #3236122 & 4159481. IT WAS REPORTED BY CUSTOMER THAT REMOVING THE NEEDLE CAP AND ATTACHING THE NEEDLE TO SYRINGE FOR DOSING. PER PATIENT NEEDLE WON'T FULLY LOCK IN AND MAY LEAK SOME MEDICINE WHILE TRYING TO INJECT. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. REPORT RECEIVED FROM PV ON 24JAN2025: PATIENT REPORTED HAVING ISSUES REMOVING THE NEEDLE CAP AND ATTACHING THE NEEDLE TO SYRINGE FOR DOSING. PER PATIENT NEEDLE WON'T FULLY LOCK IN AND MAY LEAK SOME MEDICINE WHILE TRYING TO INJECT. BD NEEDLE 23X1-1/2 LOT NUMBER(S): 3236122 & 4159481. INITIAL EMAIL STATES NO PHOTOS OR SAMPLES WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21848237 ↗MalfunctionFeb 26, 2025Complete Blockage; Complete Blockage
NO ADDITIONAL INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 21469821 ↗MalfunctionFeb 21, 2025Complete Blockage; Complete Blockage
MATERIAL#: 305194, BATCH#: 4247074. RCC RECEIVED A COMPLAINT VIA EMAIL. SOME OF THE NEEDLES ARE CLOGGED OR BLOCKED. ADDITIONAL INFO: THANK YOU FOR YOUR REPLY. UNFORTUNATELY, I DO NOT HAVE ANY ADDITIONAL INFORMATION AVAILABLE TO ME TO PROVIDE REGARDING THESE RETURN REQUESTS.
Patient problems: Insufficient Information
MAUDE report 21433539 ↗MalfunctionFeb 20, 2025Material Separation; Material Separation
NO ADDITIONAL INFORMATION RECEIVED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21421497 ↗MalfunctionFeb 5, 2025Complete Blockage; Complete Blockage
NO ADDITIONAL INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21312430 ↗MalfunctionJan 30, 2025Complete Blockage; Complete Blockage
MATERIAL #305194. BATCH #4178896. VERBATIM: WE HAVE BEEN HAVING ISSUES WITH ITEM 305194, LOT 4178896. COMPLAINT IS THAT THE MEDICATION LOCKS UP IN THE SYRINGE PREVENTING FULL ADMINISTRATION. ADDITIONAL INFORMATION: 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN THIS FORMAT MM-DD-YYYY? (B)(6) 2025. 2. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. THE PROVIDER WAS UNABLE TO ADMINISTER THE FULL INJECTION TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21273736 ↗MalfunctionJan 17, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21178954 ↗MalfunctionDec 13, 2024Complete Blockage; Complete Blockage
MATERIAL # 305194 BATCH # 4159481. WHEN SPEAKING TO PROVIDERS MY CLEAR UNDERSTANDING IS THAT WHAT WE HAVE ON HAND IS NOT WORKING FOR THEIR INJECTIONS AND CREATING BOTH SAFETY AND QUALITY CONCERNS. THEY FEEL THE 21G IS TOO LARGE AND THE 23 G IS TOO SMALL. WE MAY NEED TO FIND ANOTHER SOLUTION TO THE 23G NEEDLE? 1. IT PLUGS UP ON PROVIDERS. 2. THE CAP IS SO TIGHT THAT IT IS DIFFICULT TO REMOVE WITHOUT FEAR OF DAMAGE OR BEING POKED. 3. WE WENT FROM 1 NEEDLE TO 2, TO MEET THE NEEDS OF PATIENTS AND PROVIDERS. MAYBE WE SHOULD GO BACK TO THE 22G? 1 NEEDLE- MULTIPURPOSE (STEROID, GEL, PRP). 4. PROVIDERS CONTINUE TO USE THE 23G AS IT WAS A REPLACEMENT FOR THE 22G. THE 22G, NOW 23G, NEEDLES ARE USED FOR STEROID INJECTIONS. WE ARE FINDING THAT THE 23G NEEDLES ARE INTERMITTENTLY PLUGGED. THE 21 G NEEDLES ARE USED FOR THE GEL INJECTIONS AS THE 23G WERE TOO DIFFICULT TO ADMINISTER THE GEL INJECTIONS. THE 23G NEEDLES WOULD SOMETIMES "BACK FIRE" ON THE PROVIDERS AS THEY WERE PUSHING THE GEL INTO THE PATIENT. GELS INJECTIONS ARE MUCH DENSER AND MAKE IT DIFFICULT TO PUSH THROUGH A SMALL GAUGE. WE INITIALLY DID NOT HAVE THE 21G NEEDLES. WHEN THE 23G NEEDLES STARTED BACKFIRING WE NEEDED A LARGER GAUGE,
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20931240 ↗MalfunctionDec 2, 2024Complete Blockage; Complete Blockage
NO ADDITIONAL INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20825032 ↗MalfunctionNov 27, 2024Complete Blockage; Complete Blockage
NO ADDITIONAL INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20799228 ↗MalfunctionNov 20, 2024Complete Blockage; Complete Blockage
MATERIAL# 305194. BATCH# 3347792. IT WAS REPORTED BY CUSTOMER THAT UNABLE TO PUSH THE MEDICATION. LOT NUMBER - 3347792. PRODUCT/MODEL NUMBER: 305194.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20733928 ↗MalfunctionNov 19, 2024Break; Break
MATERIALS: 305194 BATCH#: 3320231. REPORT RECEIVED FROM PV ON 23OCT2024: PATIENT REPORTED NEEDLE WOULD BREAK FOR RECONSTITUTION NEEDLES SOMETIMES WHEN SHE ENTERED INTO VIAL AND ALSO CAP FOR DOSING NEEDLES ARE TOO TIGHT SOMETIMES AND HARD TO PULL OFF WHICH SHE WOULD THEN USE FORCE OR PLIER TOOL TO PULL CAP OFF AND IT WOULD BREAK AS WELL. PT DID NOT HAVE BOX TO PROVIDE LOT NUMBER. PRODUCT: GATTEX SAMPLE / PHOTO AVAILABILITY: NO SAMPLE OR PICTURES PROVIDED. AE: NO AE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20722618 ↗MalfunctionNov 8, 2024Complete Blockage; Leak/Splash; Complete Blockage; Leak/Splash
NO ADDITIONAL INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20645580 ↗MalfunctionOct 31, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED BY CUSTOMER THAT PATIENT OPENED SECURE CAP FROM DILUENT SYRINGE AND ATTACHED NEEDLE. UPON PUSHING DOWN ON PLUNGER THE LIQUID LEAKED OUT FROM THE JUNCTION BETWEEN THE SYRINGE THE NEEDLE. PATIENT EXPERIENCED THIS SAME ISSUE 2 MORE TIMES BEFORE SHE GOT ONE TO WORK. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED COMPONENT DESCRIPTION: BD SYRINGE: NEEDLE 23X 1-1/2. BD CATALOGUE: 3320231 EXP. 01/2029 INV DUE: 21NOV2024. REPORT RECEIVED FROM PV ON 11OCT2024: PATIENT REPORTED TO SPECIALTY PHARMACY ON (B)(6) 2024. PATIENT OPENED SECURE CAP FROM DILUENT SYRINGE AND ATTACHED NEEDLE. UPON PUSHING DOWN ON PLUNGER THE LIQUID LEAKED OUT FROM THE JUNCTION BETWEEN THE SYRINGE THE NEEDLE. PATIENT EXPERIENCED THIS SAME ISSUE 2 MORE TIMES BEFORE SHE GOT ONE TO WORK. GATTEX DOSE NOT MISSED. PATIENT HAS BEEN TAKING GATTEX FOR OVER 7 YEARS. THIS ISSUE HAS NOT OCCURRED AGAIN SINCE THE DAY THIS HAPPENED THIS MONTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20577529 ↗MalfunctionOct 28, 2024Leak/Splash; Leak/Splash
FOLLOWING THE SUBMISSION OF THE INITIAL MDR, IT WAS DETERMINED THAT THIS COMPLAINT IS A DUPLICATE OF (B)(4) AND THE COMPLAINT WILL BE CANCELLED. THE ASSOCIATED MDR WILL BE VOID.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20544379 ↗MalfunctionOct 1, 2024Complete Blockage; Complete Blockage
NO ADDITIONAL INFORMATION RECEIVED MATERIAL # 305194 BATCH # 3347792 IT WAS REPORTED BY CUSTOMER THAT SOME NEEDLES THAT ARE OCCLUDED WHEN TRYING TO BE USED. YOU ARE UNABLE TO EVEN PULL/PUSH AIR THROUGH THE NEEDLE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THE NEEDLES IN THE PACKAGE SEEM TO HAVE A DEFECT. WE HAVE SOME NEEDLES THAT ARE OCCLUDED WHEN TRYING TO BE USED. YOU ARE UNABLE TO EVEN PULL/PUSH AIR THROUGH THE NEEDLE. IT SEEMS THAT THE NEEDLE IS NOT CENTERED COMPLETELY IN THE HUB. ITEM:305194 QUANTITY AFFECTED: 2BX SERIAL/LOT NUMBER:(B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20345167 ↗MalfunctionSep 23, 2024Complete Blockage; Complete Blockage
NO ADDITIONAL INFORMATION RECEIVED. MATERIAL#: 305194; BATCH#: 4081103. IT WAS REPORTED BY THE CUSTOMER THAT TWO 23G NEEDLES THAT HAVE BEEN FAULTY WHEN TRYING TO INJECT PATIENTS. THEY SEEM TO BE OCCLUDED. ONE WOULDN¿T EVEN ALLOW HIM TO PUSH THE INJECTION THROUGH IT AT ALL, AND THE OTHER ONE WAS JUST EXTREMELY DIFFICULT TO PUSH OUT. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. HAS HAD TWO 23G NEEDLES THAT HAVE BEEN FAULTY WHEN TRYING TO INJECT PATIENTS. THEY SEEM TO BE OCCLUDED. ONE WOULDN¿T EVEN ALLOW HIM TO PUSH THE INJECTION THROUGH IT AT ALL, AND THE OTHER ONE WAS JUST EXTREMELY DIFFICULT TO PUSH OUT. PRODUCT#: 305194; LOT#: 4081103. ADDITIONAL INFO: 1. THE ISSUE DID HAPPEN DURING PATIENT USE. THIS HAPPENED WHILST DR. (B)(6) WAS INJECTING A PATIENT. THERE WERE NO INJURIES. 2. THERE WAS NO ADVERSE EVENT OR SERIOUS INJURY REPORTED. 3. I DON¿T HAVE AN EXACT DATE FOR THE INITIAL OCCURRENCE. THE SECOND ISSUE OCCURRED ON (B)(6). 4. THERE WERE 2 TOTAL OCCURRENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20280533 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K021475. One submission often covers many models, so check the product and lot details in each record.
- Z-0588-2021 · Nov 18, 2020 · TerminatedBD PrecisionGlide Needle 30G x 1/2 (0.3 mm X 13mm) REF 305106 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampoules and parts of the bo
- Z-0207-2018 · May 31, 2017 · TerminatedBD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain bl
- Z-1009-2012 · Oct 8, 2011 · TerminatedBD 30G1/2" Precision Glide" Needle Needles are used for aspiration and injection of medications
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.