N/A 305200Recalls & reported problems
Becton, Dickinson And Company · NEEDLE FILTER 19X1-1/2 TW · Class 1
Quick summary
This BD needle filter is a disposable aspiration and injection needle. Reports mostly describe contamination, leakage or splashing, and blockage, with a few mentioning eye infection. There are 99 reports, with no deaths and 6 injuries. 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
- 99
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 99 adverse event reports that list this exact device (DI 00382903052004), received between Feb 8, 2018 and Jan 14, 2026 — classified as 6 injuries, 93 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (41 reports).
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
- Device Contamination with Chemical or Other Material41
- Leak/Splash15
- Contamination7
- Complete Blockage6
- Contamination /Decontamination Problem5
- Adverse Event Without Identified Device or Use Problem4
- Break4
- Connection Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions47
- No Known Impact Or Consequence To Patient30
- No Patient Involvement9
- No Consequences Or Impact To Patient5
- Endophthalmitis4
- Insufficient Information2
- Inflammation1
- Needle Stick/Puncture1
Recent adverse event reports
The 25 most recent of 99 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 14, 2026Break; Connection Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24069063 ↗InjuryDec 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION: PER THE DSO (DRUG SAFETY OFFICER), THE PHYSICIAN REPORTED THAT PATIENTS WERE TREATED WITH STEROIDS AND SOME HE TREATED WITH ANTIBIOTICS BECAUSE THEY HAD A HIGH HYPOPYON.
Patient problems: Endophthalmitis
MAUDE report 23839877 ↗InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION: PER THE DSO (DRUG SAFETY OFFICER), THE PHYSICIAN REPORTED THAT PATIENTS WERE TREATED WITH STEROIDS AND SOME HE TREATED WITH ANTIBIOTICS.
Patient problems: Endophthalmitis
MAUDE report 23839876 ↗MalfunctionDec 17, 2025Break; Break
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23826688 ↗MalfunctionDec 13, 2025Connection Problem; Connection Problem
IT WAS REPORTED THAT THE BD NEEDLE FILTER 19X1-1/2 TW HAD A SYRINGE NEEDLE CONNECTIVITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 305200, POSSIBLE BATCH # 2199683, 2172519. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. NEEDLE CAME OFF FROM SYRINGE CAUSED LEAK OF MEDICATION. (IN DETAIL. "THE MEDICATION WAS ALREADY OUT OF THE VIAL AND INTO THE SYRINGE BUT WHEN IT WAS BEING SUPPRESSED TO GATHER THE MEDICATION TOGETHER IN THE SYRINGE THE NEEDLE CAME OFF AT THAT TIME WITH MEDICATION LEAVING THE SYRINGE AS WELL. DURING THIS TIME OF PUTTING THE NEEDLE BACK ON THE TIP OF THE SYRINGE WAS TOUCHED MAKING IT NON-STERILE".) PRODUCT#: 305200, 309628. "THE DOCTOR FELT THIS BECAME UNSTERILE AND UNSAFE TO ADMINISTER TO PATIENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23798720 ↗MalfunctionDec 2, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE BD NEEDLE FILTER 19X1-1/2 TW HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 305200, BATCH # 2172517. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. "BLACK SPECKS ON THE TOP OF THE SYRINGE WITH THE PRODUCT, AFTER THE MEDICATION WAS DRAWN FROM THE VIAL" LOT# 2172517. NEW INFORMATION PROVIDED: "SPECKS WERE OBSERVED IN BOTH SYRINGE AND IN NEEDLE (BD SYRINGE LOT # 3034733, BD NEEDLE LOT # 2172517"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23700957 ↗MalfunctionOct 28, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD NEEDLE FILTER 19X1-1/2 TW HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #305200 LOT #2172519 VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. "MEDICATION LEAKED FROM NEEDLE" UNABLE TO USE PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23407345 ↗MalfunctionAug 14, 2025Leak/Splash; Leak/Splash
IT IS REPORTED LEAKAGE. EVENT DESCRIPTION: FILTER NEEDLE LEAKED UPON PULLING UP DRUG. PRODUCT#: 217118, LOT#: 2172519. ADDITIONAL INFORMATION: ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22809891 ↗MalfunctionAug 14, 2025Leak/Splash; Leak/Splash
IT IS REPORTED LEAKAGE. EVENT DESCRIPTION: FILTER NEEDLE LEAKED UPON PULLING UP DRUG. PRODUCT#: 217118. LOT#: 2172519. ADDITIONAL INFORMATION: ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22809723 ↗MalfunctionAug 11, 2025Leak/Splash; Leak/Splash
IT IS REPORTED LEAKAGE. EVENT DESCRIPTION: MATERIAL #305200 LOT #2172519 FILTER NEEDLE LEAKED UPON PULLING UP DRUG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22777824 ↗MalfunctionAug 11, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22777812 ↗MalfunctionJul 16, 2025Connection Problem; Connection Problem
DESCRIPTION: CONNECTION ISSUES. EVENT DETAILS: DR HAD TO USE NEW VIAL FOR PATIENT DUE TO OLD VIAL'S FILTER NEEDLE FELL OFF WHILE PULLING UP MEDICATION. PT RECEIVED TREATMENT WITH NEW VIAL. PRODUCT NUMBER - 305200. LOT NUMBER - 2172517.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22523987 ↗MalfunctionJul 16, 2025Break; Break
DESCRIPTION: "FILTER NEEDLE BROKEN". NO PORTION OF THE BROKEN/SPOILED PRODUCT HAS BEEN ADMINISTERED, AND NO PORTION OF THE BROKEN/SPOILED PRODUCT IS INTENDED TO BE ADMINISTERED TO ANY PATIENT. THERE WAS NO HARM TO THE PATIENT, HCP OR USER. FILTER NEEDLE IS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22519557 ↗MalfunctionJul 8, 2025Leak/Splash; Leak/Splash
EVENT DETAILS: "FILTER NEEDLE LEAKED UPON PULLING UP DRUG. INSUFFICIENT RESIDUAL MEDICATION." NO PORTION OF THE BROKEN/SPOILED PRODUCT HAS BEEN ADMINISTERED, AND NO PORTION OF THE BROKEN/SPOILED PRODUCT IS INTENDED TO BE ADMINISTERED TO ANY PATIENT. THERE WAS NO HARM TO THE PATIENT, HCP OR USER. FILTER NEEDLE IS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22436369 ↗MalfunctionJun 19, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED BY CUSTOMER THAT "UNKNOWN BLACK SPOTS ON SYRINGE AND NEEDLE" VERBATIM: MATERIAL # 305200 & BATCH # 2199683. PLEASE INITIATE A COMPLAINT INVESTIGATION AND HAVE IT COMPLETED WITHIN 45-60 DAYS REFERENCING ASTELLAS RECORD # CN-011940 FOR ¿UNKNOWN BLACK SPOTS ON SYRINGE AND NEEDLE¿. PER THE NURSE AT THE EYE CLINIC, THE BLACK SPOTS APPEAR TO BE INSIDE THE NEEDLE CAP, AND INSIDE THE SYRINGE. SEE ATTACHED REPORT FOR DETAILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22289237 ↗MalfunctionMay 26, 2025Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Activation, Positioning or Separation Problem; Detachment of Device or Device Component
ADDITIONAL INFORMATION FROM CUSTOMER: IT HAS BEEN CONFIRMED THAT THE NEEDLE THAT CAME OFF THE SYRINGE WAS A 30-GAUGE NEED SUPPLIED BY THE EYE CLINIC AND NOT THE FILTER NEEDLE THAT CAME WITH THE IZERVAY KIT. PLEASE CANCEL THE INVESTIGATION REQUEST FOR THE FILTER NEEDLE ((B)(4)).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22085151 ↗MalfunctionMay 19, 2025Contamination; Contamination
MATERIAL # 305200, LOT # 2172519, IT WAS REPORTED BY CUSTOMER THAT THEY FOUND REDDISH BROWN HARD SUBSTANCE ON THE NEEDLE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED SUBSTANCE ON NEEDLE-CONTAMINATED" RED BROWN HARD SUBSTANCE ON THE FILTER NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22044245 ↗MalfunctionMar 27, 2025Connection Problem; Connection Problem
MATERIAL #305200 BATCH #2172517. IT WAS REPORTED BY CUSTOMER THAT THE NEEDLE CAME OFF OF SYRINGE. RCC RECEIVED A COMPLAINT VIA EMAIL. "NEEDLE CAME OFF OF SYRINGE". LOT#: 2172517. 19MAR2025 - A REPORT WAS RECEIVED FROM ASTELLAS SAFETY IN THE PRODUCT COMPLAINTS EMAIL BOX REGARDING IZERVAY, THE REPORT STATES, "DRUG WAS DRAWN UP USING STERILE TECHNIQUE, DURING PRIMING, NEEDLE CAME OFF OF SYRINGE AND MEDICATION EJECTED FROM SYRINGE", PER THE BREAKAGE AND SPOILAGE REPLACEMENT FORM, THE SERIAL NUMBER IS (B)(6). 19MAR2025 - EMAIL NOTIFICATION SENT TO SAFETY, 19MAR2025 - REFERENCE THE ATTACHED REPORTS REGARDING THE LOT QUERY AND SIMILAR DEFECT QUERY, 19MAR2025 - PER THE ASTELLAS COC, SYRINGE LOTS 3027073 AND 3027085 WERE USED IN IZERVAY KIT LOT T16240047A, 19MAR2025 - INVESTIGATION REQUEST SENT TO BD FOR SYRINGE LOTS 3027073 AND 3027085, IZERVAY KIT LOT T16240047A. 20MAR2025 - CALLED THE EYE CLINIC, SPOKE TO A REPRESENTATIVE, NEITHER THE HCP NOR OFFICE MANAGER WERE AVAILABLE, LEFT A MESSAGE FOR THE OFFICE REQUESTING A CALL BACK TO VERIFY WHAT NEEDLE (FILTER OR ADMINISTRATION) CAME OFF THE SYRINGE. 20MAR2025 - IT WAS DETERMINED THAT SINCE IT WAS UNKNOWN WHAT NEEDLE CAME OFF THE SYRINGE, AN I
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21710714 ↗MalfunctionFeb 19, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21411492 ↗MalfunctionDec 16, 2024Defective Component; Defective Component
MATERIAL #: 305200 BATCH#: 2172517. A REPORT WAS RECEIVED FROM ASTELLAS SAFETY IN THE PRODUCT COMPLAINTS EMAIL BOX REGARDING IZERVAY. THE REPORT STATES, ¿FILTER NEEDLE WAS DAMAGED. MEDICINE WAS LOST¿ LOT 2172517.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20940687 ↗MalfunctionSep 30, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
ADDITIONAL INFORMATION RECEIVED. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO ADVERSE EVENTS OR MISSED DOSES. MATERIAL # 305200. BATCH # 1074204. IT WAS REPORTED BY CUSTOMER THAT THE PHYSICIAN NOTICED A FIBER INSIDE THE SYRINGE BODY WITH THE MEDICATION. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. THE PHYSICIAN NOTICED A FIBER INSIDE THE SYRINGE BODY WITH THE MEDICATION. IT IS UNKNOWN IF THE FIBER WAS PRESENT IN THE AFFECTED VIAL OR IF IT WAS ALREADY PRESENT IN THE SYRINGE PRIOR TO DOSE PREPARATION. THE AFFECTED PRODUCT WAS NOT ADMINISTERED TO A PATIENT. NO ADVERSE EVENT OR MISSED DOSES WERE REPORTED AS A RESULT OF THE REPORTED EVENT. THE REPORTER HAS THE AFFECTED PRODUCT AVAILABLE FOR RETRIEVAL AND IS REQUESTING A REPLACEMENT FOR ONE EYLEA VIAL. BD LOT: 305200 / 1074204.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20332469 ↗MalfunctionSep 23, 2024Packaging Problem; Packaging Problem
NO ADDITIONAL INFORMATION RECEIVED MATERIAL #: 305200, BATCH#: 2172517. IT WAS REPORTED BY CUSTOMER THAT NOT SURE WHO I NEED TO LET KNOW ABOUT THIS BUT ABOUT THIS SAMPLE IZERVAY IN WS: PER DR. (B)(6), THIS WAS A NON-STERILE ITEM AS THE FILTER NEEDLE THAT IT COMES WITH WAS OPEN WHEN HE OPENED THE BOX. THE BOX WAS CLOSED AND SEALED. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PER THE EMAIL FROM THE HCP, "HELLO, NOT SURE WHO I NEED TO LET KNOW ABOUT THIS BUT ABOUT THIS SAMPLE IZERVAY IN WS: PER DR. (B)(6), THIS WAS A NON-STERILE ITEM AS THE FILTER NEEDLE THAT IT COMES WITH WAS OPEN WHEN HE OPENED THE BOX. THE BOX WAS CLOSED AND SEALED." ITEM# 305200. LOT#2172517.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20280475 ↗MalfunctionJul 25, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
MATERIAL #: 305200. BATCH#: 2172517. IT WAS REPORTED BY CUSTOMER THAT FILTER NEEDLE CONTAMINATED WHILE DRAWING UP MEDICATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19825941 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.