SURGUARD3 SG3+2051Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 14806017507777), received between Apr 4, 2018 and May 11, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2025Unsealed Device Packaging; Unsealed Device Packaging

  THE USER FACILITY REPORTED THAT DURING A CUSTOMER INSPECTION, IT WAS DISCOVERED THAT THE PACKAGING OF THE NEEDLES WAS NOT PROPERLY SEALED, WITH SOME PACKAGES HAVING OPENINGS. THESE OPENINGS COULD COMPROMISE THE STERILITY OF THE NEEDLES. THE EVENT OCCURRED PRE-TREATMENT, WITH NO PATIENT INVOLVEMENT. OUT OF THE 60 PRODUCTS IDENTIFIED WITH ISSUES, THE CUSTOMER PROVIDED ONLY 8 SAMPLES THAT HAD CLEAR SEALING DEFECTS. THE REMAINING PRODUCTS WERE DISCARDED BY THE CUSTOMER DURING INSPECTION AS NON-CONFORMING ITEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21999928 ↗
• MalfunctionMar 15, 2024Break; Break

  THE USER FACILITY REPORTED THAT THE INVOLVED NEEDLE WAS BROKEN USING RISPERDAL CONSTA. THE PRODUCT WAS NOT ADMINISTERED TO THE PATIENT AND THE PATIENT'S HEALTH WAS NOT HARM. THE EVENT OCCURRED PRE-TREATMENT. THE FINAL PATIENT IMPACT WAS NOT HARMED. THE PATIENT WAS NOT INJURED DURING THE EVENT AND MEDICAL/SURGICAL INTERVENTION WAS NOT NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18911506 ↗
• MalfunctionAug 27, 2023Break; Break

  THE USER FACILITY REPORTED THAT BEFORE INJECTION THE INVOLVED TERUMO SURGUARD3 SAFETY NEEDLE WAS FOUND BROKEN. TREATMENT WAS STOPPED. THE EVENT OCCURRED PRE-TREATMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17629040 ↗
• MalfunctionJul 25, 2022Break; Break

  THE USER FACILITY REPORTED THAT A RISPERDAL CONSTA 50MG NEEDLE BROKE WHEN ADMINISTERED. THERE WAS NO PATIENT INJURY OR WAS MEDICAL OR SURGICAL INTERVENTION REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 15091080 ↗
• MalfunctionDec 1, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE USER FACILITY REPORTED THAT THE INJECTION PROVIDER ATTEMPTED TO REMOVE A 2INCH KIT NEEDLE FROM THE SYRINGE BUT WAS UNABLE TO DO SO. THE NURSE STATED SHE ATTEMPTED TO REMOVE THE NEEDLE, WHICH WAS FULLY SHEATHED, FROM THE SYRINGE BUT IT WAS JUST TWISTING AROUND IN THE HUB OF THE SYRINGE INSTEAD OF COMING OFF. SHE STATED THAT THE NEEDLE THEN POPPED OFF THE SYRINGE, AND SHE RECEIVED A NEEDLE STICK ON THE MIDDLE FINGER OF HER LEFT HAND, SLIGHTLY BELOW THE NAILBED. SHE STATED SHE FOLLOWED THEIR FACILITY'S NEEDLE STICK PROTOCOL, AND HAD IT LOOKED AT THE ER. ADDITIONAL INFORMATION WAS RECEIVED ON 05NOVEMEBER2021: THE NEEDLE THAT WAS BEING ATTEMPTED TO BE REMOVED FROM THE SYRINGE WAS THE NEEDLE THAT CAUSED NEEDLE STICK AND WAS ALREADY USED. THE NEEDLE WAS CLOGGED, THEREFORE THEY NEEDED TO CHANGE THE NEEDLE. ADDITIONAL INFORMATION WAS RECEIVED ON 08NOVEMEBER2021: THE SAFETY SHEATH WAS ON THE NEEDLE THE WHOLE TIME SHE WAS IN CONTACT WITH IT. IT WAS NOT DEACTIVATED DURING NEEDLE REMOVAL. IT WAS CONFIRMED THAT WHEN THE NEEDLE POPPED OFF THE SYRINGE, WAS WHEN THE NEEDLE STICK OCCURRED DESPITE HAVING HAD THE SHEATH ENGAGED. ADDITIONAL INFORMATION WAS RECEIVED ON 10NOVEMEBER2021: IT WAS REPORT

  Patient problems: Needle Stick/Puncture

  MAUDE report 12911193 ↗
• MalfunctionApr 4, 2018Break; Use of Device Problem; Break; Use of Device Problem

  THE USER FACILITY REPORTED THAT WHILE ADMINISTERING VIVITROL USING THE 2-INCH NEEDLE, THE NEEDLE POPPED, AND BROKE OFF. THE NURSE REPORTED THAT AS SHE WAS INJECTING THE MEDICATION WHILE THE NEEDLE POPPED, BROKE OFF AND THE MEDICATION WAS STILL IN THE SYRINGE OR SOME OF IT WAS AFTER IT EXPLODED AS THE NURSE WAS PUSHING IT IN. THE NEEDLE POPPED OFF THE SYRINGE SO THE NURSE ATTACHED THE NEEDLE TO THE SYRINGE AND THE TOP PART TO THE NEEDLE WAS STILL ON BUT THE NEEDLE BROKE OFF. THE NEEDLE BROKE OFF INSIDE THE PATIENT, BUT THE NURSE WAS ABLE TO THE PULL IT OUT. THE NURSE CONFIRMED SHE FOLLOWED INSTRUCTIONS FOR PREPARING VIVITROL PER THE PRESCRIBING INFORMATION AND THE VIVITROL KIT WAS TAKEN OUT OF THE REFRIGERATOR TO ALLOW IT TO REACH ROOM TEMPERATURE PRIOR TO PREPARING IT FOR ADMINISTRATION. THE MEDICATION COULD NOT BE ADMINISTERED AS MEDICATION SPILLED ONTO PATIENT AND FLOOR THEREFORE THE PATIENT DID NOT RECEIVE THE DOSE OF MEDICATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7396511 ↗