SURGUARD3 SG3+2025Recalls & reported problems
Terumo (Philippines) Corporation · SURGUARD3 Safety Hypodermic Needle · Class 2
All models of SURGUARD3 (19)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 14806017509641), received between Nov 20, 2020 and Nov 20, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 20, 2020Break; Break
THE USER FACILITY REPORTED THAT THEY HAD AN ISSUE WITH THE TERUMO 1" NEEDLE. A PATIENT CAME IN FOR THEIR VIVITROL INJECTION, AND WAS UNABLE TO GET THEIR SCHEDULED DOSE DUE TO THE NEEDLE SEPARATING FROM THE SYRINGE DURING PREPARATION. THE NURSE STATED THERE WAS NO PACKAGE DAMAGE NOTED TO THE KIT PRIOR TO PREPARATION. UPON OPENING THE KIT, THE NURSE STATED THE DRY POWDER VIAL CONTAINED, "MULTIPLE, TINY CLUMPS." SHE TAPPED THE VIAL ON THE INSIDE OF HER PALM AND THE POWDER WAS MOVING FREELY IN THE VIAL. USING THE KIT PREPARATION NEEDLE AND KIT SYRINGE, SHE WITHDREW THE DILUENT (VOLUME UNKNOWN) AND INSERTED THE NEEDLE INTO THE POWDER VIAL. SHE STATED AS SHE WAS PUSHING THE DILUENT INTO THE POWDER VIAL, "NEEDLE WENT FLYING OFF," AND SOME OF THE DILUENT SPRAYED OUT. SOME OF THE DILUENT WENT INTO HER EYES, HOWEVER, THERE WAS NO INJURY AS RESULT. NURSE WAS UNABLE TO SPECIFY WHICH PART OF THE NEEDLE "WENT FLYING." UPON ASKING IF THE SHAFT OF THE NEEDLE SEPARATED FROM THE HUB, THE NURSE STATED "YES". NO FURTHER ACTION WAS TAKEN, AND PATIENT DID NOT RECEIVE THEIR SCHEDULED DOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10875368 ↗
Other Needle, hypodermic, single lumen devices
- BD Nano 2nd Gen 320550Becton Dickinson Pen Limited · Needle, hypodermic, single lumen2,044 reports
- BD SafetyGlide 305916Becton, Dickinson And Company · Needle, hypodermic, single lumen1,767 reports
- BD Nano Ultra-Fine 320122Becton Dickinson Pen Limited · Needle, hypodermic, single lumen601 reports
- N/A 305106Becton, Dickinson And Company · Needle, hypodermic, single lumen1 recall467 reports
- N/A 305110Becton, Dickinson And Company · Needle, hypodermic, single lumen418 reports
- BD Safe-Clip 328235Becton, Dickinson and Company Inc · Needle, hypodermic, single lumen268 reports
- BD Ultra-Fine 320109Becton Dickinson Pen Limited · Needle, hypodermic, single lumen229 reports
- BD AutoShield Duo 329515Becton, Dickinson And Company · Needle, hypodermic, single lumen208 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page