N/A 305211Recalls & reported problems

Summary

The FDA's MAUDE database contains 425 adverse event reports that list this exact device (DI 00382903052110), received between Nov 7, 2017 and Sep 29, 2026 — classified as 64 injuries, 361 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (150 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 425 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Break; Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935058 ↗
• MalfunctionSep 23, 2026Leak/Splash; Connection Problem

  It was reported, NEEDLE FILTER BLUNT FILL, filter needle not securely attached to luer lock, causing leak.The following was provided by the initial provider: On (b)(6)2026, xxxxx received a complaint from a reporter regarding a xxxxxx, Lot 2189856. The reporter stated that the included filter needle did not securely attach to the Luer Lock connection, resulting in difficulty drawing up the medication properly. The physician further reported that when attempting to expel excess air bubbles through the filter needle, medication leaked from the needle hub at the Luer Lock connection, resulting in product waste. The vial was prepared for administration using a syringe and needle; however, the product was not administered to the patient. No adverse event was reported, and there was no risk to patient safety. No further issues have been reported.Event date: (b)(6)2026,Root Cause (Undetermined): Root Cause (Undetermined).Potential Root Cause(s): Incomplete engagement between the filter needle hub and the syringe Luer Lock connection, resulting in an inadequate seal and leakage during medication draw-up or air purging. User technique during assembly, including failure to fully secure the f

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868478 ↗
• MalfunctionSep 2, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50566051 ↗
• MalfunctionMay 28, 2026Contamination

  IT IS REPORTED, BD NEEDLE FILTER BLUNT FILL 18X1-1/2, FOREIGN MATTER ON THE CANNULA. DESCRIPTION: IT WAS REPORTED THAT WHILE PREPARING TO EXTRACT THE DRUG, CONTAMINATION WAS DETECTED ON THE NEEDLE. SO, IT IS IMPOSSIBLE TO USE FOR PATIENT. IT WAS REPORTED THAT THE DRUG WAS USED WITH A DIFFERENT NEEDLE. (THE CONTAMINATED NEEDLE WAS NOT USED.) THE HCP RESPONDED THAT HE WAS FAMILIAR WITH VABYSMO BECAUSE SHE HAD USED IT SEVERAL TIMES AND THAT SHE HAD FOLLOWED THE GUIDANCE WELL. INTERNAL ROCHE ADDITION: BLACK PARTICLES WERE OBSERVED ALL ALONG THE CANNULA. HARM TO THE PATIENT: NO. ADDITIONAL INFORMATION: THE COUNTRY WHERE EVENT OCCURRED IS SOUTH KOREA (REPUBLIC OF KOREA) AS PER NOTIFICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25317483 ↗
• MalfunctionMay 13, 2026Leak/Splash

  IT WAS REPORTED BY CUSTOMER THAT SYRINGE WAS LEAKING, NEEDLE DIS-GUARDED. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT (B)(6) 2026 WHAT WAS THE MEDICATION/FLUID IN USE AT THE TIME OF THE EVENT? IZERVAY WHEN WAS THIS DEFECT OBSERVED? DURING OR BEFORE USE? THE LEAK OCCURRED AFTER THE MEDICATION WAS WITHDRAWN FROM THE VIAL. BEFORE ADMINISTRATION TO THE PATIENT. WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? YES, ANOTHER KIT HAD TO BE USED BY THE HCP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25160310 ↗
• MalfunctionApr 29, 2026Contamination

  IT IS REPORTED, FOREIGN MATTER WAS FOUND INSIDE THE NEEDLE CANNULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25032097 ↗
• MalfunctionApr 27, 2026Contamination

  IT IS REPORTED, PARTICLE OBSERVED IN SYRINGE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25000930 ↗
• MalfunctionApr 15, 2026Device Contamination with Chemical or Other Material

  IT IS REPORTED, FOREIGN MATTER ON NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24885355 ↗
• MalfunctionApr 8, 2026Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24816588 ↗
• MalfunctionApr 6, 2026Contamination

  IT WAS REPORTED BY THE CUSTOMER THAT WHITE RESIDUE ON THE SUPPLIED NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24789715 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: Endophthalmitis

  MAUDE report 24605268 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: Endophthalmitis

  MAUDE report 24605262 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: Endophthalmitis

  MAUDE report 24605255 ↗
• MalfunctionFeb 27, 2026Contamination

  DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24469932 ↗
• MalfunctionFeb 25, 2026Contamination

  A PATIENT REPORTED SHE OBSERVED A BLACK SUBSTANCE ON THE NEEDLE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444984 ↗
• MalfunctionFeb 24, 2026Flaked

  IT IS REPORTED FOREIGN MATTER. DESCRIPTION: BLUNT FILL NEEDLE WAS FLAKING. THE WHITE CEMENT THAT SEALS THE RED CONNECTOR AND THE NEEDLE TOGETHER WAS FLAKING WHITE BITS DOWN ONTO THE HEPARIN VIAL THE RN WAS TRYING TO DRAW UP VIAL. SOME FLAKES DID ENTER THE VIAL, MAKING IT UNUSABLE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24428332 ↗
• MalfunctionFeb 16, 2026Contamination

  IT IS REPORTED FOREIGN MATTER. A PHYSICIAN DISCOVERED IRON FILINGS ON THE ROCHE TRANSFER FILTER NEEDLE DURING PREPARATION. THE PHYSICIAN SUBSEQUENTLY REPLACED IT WITH THE HOSPITAL'S OWN NEEDLE TO PERFORM THE INJECTION; THE ROCHE TRANSFER FILTER NEEDLE WAS NOT USED ON THE PATIENT. IT WAS CONFIRMED THAT THE ROCHE TRANSFER FILTER NEEDLE WAS PROPERLY SEALED BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24349563 ↗
• MalfunctionFeb 16, 2026Unsealed Device Packaging

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24345056 ↗
• MalfunctionJan 20, 2026Contamination /Decontamination Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24115307 ↗
• MalfunctionJan 4, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD NEEDLE FILTER BLUNT FILL 18X1-1/2 CONTAINED FOREIGN MATTER. VERBATIM: THE PHYSICIAN NOTED BLACK SPOTS ON THE NEEDLE THAT WAS PROVIDED WITH THE EYLEA KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23954433 ↗
• MalfunctionDec 13, 2025Break; Break

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23798674 ↗
• MalfunctionDec 11, 2025Break; Break

  IT WAS REPORTED THAT THE BD NEEDLE FILTER BLUNT FILL 18X1-1/2 NEEDLE HUB WAS CRACKED / DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT " A T1 DISTRIBUTOR OF ROCHE REPORTED TO HOTLINE THAT A HOSPITAL REPORTED IN SEPTEMBER AND STATED THAT THERE WAS AN ISSUE WITH A TRANSFER NEEDLE OF VABYSMOS WHEN THEY USED IT. AFTER RECEIVING THE PICTURES OF COMPLAINT SAMPLE, IT SHOWED THE PLASTIC MOUTH PART OF THE TRANSFER NEEDLE WAS BROKEN." THE COMPLAINT HAS BEEN CLASSIFIED AS ¿NEEDLE ¿ DAMAGED - OTHER¿. HARM TO THE PATIENT--NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778259 ↗
• MalfunctionNov 24, 2025Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE BD NEEDLE FILTER BLUNT FILL 18X1-1/2 HAD A PACKAGE INTEGRITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A DEFECT WAS IDENTIFIED IN THE SEALING OF THE PRODUCT PACKAGING. THE SEAL WAS FOUND TO BE INCOMPLETE OR COMPROMISED, POTENTIALLY AFFECTING PRODUCT INTEGRITY AND STERILITY. THIS ISSUE WAS OBSERVED DURING ROUTINE INSPECTION PRIOR TO DISTRIBUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23631221 ↗
• MalfunctionNov 18, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD NEEDLE FILTER BLUNT FILL 18X1-1/2 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE TTSH EYE CLINIC MANAGER INFORMED THAT THE FILTER NEEDLE CO-PACKAGED WITH VABYSMO VIAL HAD A BLACK DOT ON IT. AFTER MOVING THE NEEDLE, THE SMALL PIECE DROPPED ON THE CAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23581960 ↗
• MalfunctionNov 13, 2025Contamination; Contamination

  IT WAS REPORTED THAT THE BD NEEDLE FILTER BLUNT FILL 18X1-1/2 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT "AS PART OF OUR QUALITY CONTROL, WE HAVE BEEN MADE AWARE THAT VISIBLE PARTICLE ADHESIONS HAVE BEEN DETECTED ON SOME OF YOUR NEEDLE FILTERS ((B)(4), LOT 4212641). THESE ARE BLACK RESIDUES WHOSE MOBILITY HAS NOT YET BEEN CONCLUSIVELY ASSESSED. WE WOULD THEREFORE LIKE TO ASK YOU TO LET US KNOW WHETHER YOU ARE ALREADY AWARE OF THIS PHENOMENON AND WHETHER ANY QUALITY REPORTS OR ASSESSMENTS HAVE ALREADY BEEN MADE. WE ARE PARTICULARLY INTERESTED IN YOUR ASSESSMENT WITH REGARD TO PATIENT SAFETY AND POSSIBLE EFFECTS DURING USE. WE WOULD BE VERY GRATEFUL FOR YOUR FEEDBACK AND ANY FURTHER INFORMATION ON THE AFFECTED LOT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23541959 ↗