SURGUARD3 SG3+2125Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 14806017509573), received between Jun 12, 2018 and Jan 4, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 4, 2023Activation Problem; Activation Problem

  THE USER FACILITY REPORTED THAT AFTER THE NURSE ADMINISTERED THE PRODUCT THE NEEDLE DIDN'T CLOSE AND CAUGHT HER GLOVE, AND SHE INCURRED A NEEDLE STICK. THE NURSE STATED THAT THE SAFETY NEEDLE WAS FLIMSY. THE NURSE SAID THAT THERE WAS A LITTLE BLOOD AND THAT IT WAS MORE OF A PRICK. BLOOD WORK WAS DONE TO CHECK. SHE CONFIRMED THAT THE ONLY ISSUE WAS THE SAFETY NEEDLE GUARD BEING FLIMSY AND STUCK HERSELF.

  Patient problems: Needle Stick/Puncture

  MAUDE report 16099372 ↗
• MalfunctionJan 4, 2023Activation Problem; Activation Problem

  THE USER FACILITY REPORTED THAT THE NEEDLE SAFETY GUARD DID NOT SNAP IN AND THE NURSE STUCK HERSELF WITH A USED NEEDLE THROUGH HER GLOVE. SHE FURTHER STATED SHE WAS TRYING TO PUSH ON THE "ORANGE THING" WITH HER THUMB UP TO SECURE THE NEEDLE, BUT IT DID NOT GO UP AND DID NOT STAY IN PLACE AND SHE TRIED TO USE HER INDEX FINGER BUT THEN GOT STUCK BY THE NEEDLE AT THE TIP OF THE INDEX FINGER. SHE STATED IT WAS A "GOOD STICK" AS IT DID NOT STOP BLEEDING FOR A MINUTE. SHE DID GET BLOOD WORK DONE AND IS MONITORING AND TAKING THE SAFETY PRECAUTIONS. SHE CONFIRMED IT WAS THE DELTOID 1-INCH NEEDLE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 16096587 ↗
• 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 15091072 ↗
• MalfunctionSep 11, 2020Accessory Incompatible; Malposition of Device; Device Dislodged or Dislocated; Accessory Incompatible; Malposition of Device; Device Dislodged or Dislocated

  THE USER FACILITY REPORTED THAT THE NURSE HAD ISSUES ADMINISTERING AN INJECTION TO HER PATIENT. THE NURSE MIXED THE SOLUTION THE WAY THAT SHE WAS SUPPOSED TO. SHE INJECTED THE NEEDLE AND THE NEEDLE WOULD NOT INJECT. MEDICATION DID NOT COME OUT OF THE NEEDLE. SHE PULLED IT OUT AND TRIED TO DO IT AGAIN AND IT JUST WOULD NOT COME OUT. SHE TRIED TO RETRACT THE NEEDLE AND IT DID NOT WORK. SHE REPLACED THE NEEDLE AND IT STILL DID NOT WORK; THE NEEDLE USED WAS A DELTOID NEEDLE. SHE REPLACED THE NEEDLE AGAIN, WITH A NEEDLE THAT CAME WITH THE KIT (GLUTEAL NEEDLE). THE GLUTEAL NEEDLE WAS USED TO INJECT THE CONSUMER IN THE ARM ABOUT 2 INCHES IN AND IT ENDED UP WORKING FINE. AS THE NURSE MADE MULTIPLE ATTEMPTS TO INJECT THE MEDICATION WITH THE DELTOID NEEDLE AND WAS NOT SUCCESSFUL UNTIL THE NEEDLE WAS CHANGED. IN THIS EVENT THE NURSE INCURRED A NEEDLE STICK WITH THE UNINTENDED NEEDLE. THE DOSE WAS 50 UNIT: MILLIGRAMS. THE ROUTE OF ADMINISTRATION WAS INTRAMUSCULAR. PATIENT RECEIVED INTENDED DOSE. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 03SEPT2020: THE NEEDLE STICK HAPPENED DUE TO CHANGING NEEDLES AS THE DELTOID NEEDLE THAT CAME

  Patient problems: Needle Stick/Puncture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10521591 ↗
• MalfunctionJun 12, 2018Break; Break

  THE USER FACILITY REPORTED THAT WHEN ATTEMPTING TO ADMINISTER THE PRODUCT THE NEEDLE WAS BROKEN. THE PATIENT STARTED A RISPERDAL CONSTA. THE PHYSICIAN RECONSTITUTED THE MEDICATION, WHEN ATTEMPTING TO ADMINISTER THE PRODUCT THE NEEDLE WAS BROKEN; THIS COMPLAINT RESULTED IN A MISSED DOSE FOR THE PATIENT. IT WAS REPORTED THAT THE PATIENT WAS FINE AND RECEIVED THE DOSE THE FOLLOWING DAY. ADDITIONAL INFORMATION RECEIVED ON 5/10/2018: IT WAS REPORTED THAT THE NEEDLE BROKE AS THE DOCTOR WAS PREPARING THE INJECTION. IT WAS REPORTED THAT IT WAS THE DELTOID NEEDLE THAT WAS BROKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7591663 ↗