SURGUARD3 SG3+2038Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 14806017508682), received between Jun 17, 2019 and Jul 7, 2023 — classified as 3 malfunctions.

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2023Break; Break

  THE USER FACILITY REPORTED THAT THE HUB BROKE OFF. THEN THE SAFETY FELL OFF THE NEEDLE CAUSING THE NEEDLE TO STICK HER IN THE FINGER. THE CLEAR SYRINGE HUB ON THE SYRINGE AND THE YELLOW HUB THAT ATTACHES TO THE SYRINGE BROKE OFF THE DEVICE. THE NEEDLE CLOGGED AND THE STAFF REMOVED THE NEEDLE FROM THE PATIENT AND CLOSED THE SAFETY. WHEN THEY WENT TO REMOVE THE NEEDLE FROM THE HUB, THE HUB BROKE OFF AND THEN THE SAFETY FELL OFF THE NEEDLE AND THE NEEDLE STUCK THE FINGER. THE SAFETY ONE THAT SNAPS INTO PLACE. THE EVENT OCCURRED INTRA-OPERATIVE. THE PROCEDURE PERFORMED WAS A INTRAMUSCULAR INJECTION. NO BLOOD LOSS WAS REPORTED. THE PATIENT WAS NOT INJURED DURING THE EVENT AND MEDICAL OR SURGICAL INTERVENTION WAS NOT REQUIRED. THERE WAS NOT A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED 14 JUN 2023: THEY CLOSED THE SAFETY SHEATH ACTIVATED AFTER THE NEEDLE WAS REMOVED THE PATIENT. THE STAFF REMOVED THE NEEDLE FROM THE PATIENT AND CLOSED THE SAFETY AND WENT TO REMOVE THE NEEDLE FROM THE HUB, AND THE HUB BROKE OFF AND THEN THE SAFETY FELL OFF THE NEEDLE. THE NURSE STUCK HER FINGER

  Patient problems: Needle Stick/Puncture

  MAUDE report 17283573 ↗
• MalfunctionJun 4, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE USER FACILITY REPORTED THAT THE INVOLVED TERUMO 1.5" NEEDLE WAS USED TO ADMINISTER 882MG OF ARISTADA TO A PATIENT FOR TREATMENT OF SCHIZOAFFECTIVE DISORDER. THE PATIENT RECEIVED 1/4TH OF THE DOSE IN HIS RIGHT DELTOID MUSCLE DUE TO A NEEDLE CLOG DURING ADMINISTRATION. THE NURSE DID NOT ATTEMPT TO INJECT THE REMAINING AMOUNT AS SHE WAS UNABLE TO DETACH THE NEEDLE FROM THE SYRINGE AND THE "SAFETY LOCK BECAME LOOSE". THE NURSE REPORTED USING A 20G, 1.5 INCH KIT NEEDLE AT THE TIME. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10118066 ↗
• MalfunctionJun 17, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THE USER FACILITY REPORTED THAT ALKERMES, INC. RECEIVED AN ISSUE REPORT INVOLVING THE TERUMO 1 1/2" NEEDLE BEING PACKAGED INCORRECTLY. NALTREXONE SA INJECTION FROM ALKERMES PHARMACEUTICALS LOT HAD 1 INCH NEEDLES INCLUDED IN PACKAGING LABELED AS 1.5 INCH NEEDLES. NURSES NOTED AND DID NOT ADMINISTER TO PATIENTS. USED 1.5 INCH NEEDLES AVAILABLE SEPARATELY IN THE CLINIC.

  Patient problems: No Patient Involvement

  MAUDE report 8704980 ↗