SURGUARD3 SG3+1916Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 14806017510715), received between Apr 19, 2023 and Aug 27, 2026 — classified as 2 injuries, 19 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Connection Problem

  Terumo received the following information: It was reported that the needle detached from the cartridge when slight pressure was applied to the safety cap. The needle fell off the cartridge and onto the floor before the safety cap could fully enclose the needle.Additional information was received on (b)(6) 2025: The reporter screwed the needle onto the barrel, pinched the patient's skin, and administered the medication as intended. After the injection, while attempting to engage the safety cap by pressing it against a bench with minimal force, the needle detached from the device and fell to the floor. The needle did not detach during administration; it detached during activation of the safety cap. There was no patient harm reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50479180 ↗
• MalfunctionAug 26, 2026Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50452125 ↗
• MalfunctionDec 3, 2025Connection Problem; Connection Problem

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE USER FACILITY REPORTED THAT THEY HAD AN INCIDENT RECENTLY WITH A NEEDLE THAT HAD FALLEN OFF THE CARTRIDGE WITH SLIGHT PRESSURE ON THE SAFETY CAP. IT HAD FALLEN OFF ONTO THE FLOOR WITHOUT THE CAP ENCLOSING THE NEEDLE. ADDITIONAL INFORMATION WAS RECEIVED ON 07NOV2025: THEY SCREWED THE NEEDLE HEAD ONTO THE BARREL, PINCHED THE PATIENT'S SKIN, AND THEN ADMINISTERED THE MEDICATION. WHEN THEY PULLED THE NEEDLE OUT AND WENT TO CLOSE THE SAFETY CAP BY PRESSING IT ON THE BACK OF THEIR HAND, WITHOUT MUCH FORCE, THE NEEDLE HEAD FELL OFF, PRICKED THE BACK OF THEIR HAND, AND DROPPED TO THE FLOOR.

  Patient problems: Needle Stick/Puncture

  MAUDE report 23712127 ↗
• MalfunctionOct 21, 2025Activation Failure; Activation Failure

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. THE SAFETY SHIELD CLICKED; HOWEVER, THE NEEDLE DID NOT LOCK. ADDITIONAL INFORMATION WAS RECEIVED ON 29SEP2025: THE NEEDLE WAS NOT BENT. THERE WAS NO SAMPLE OR PHOTO AVAILABLE. THE PATIENT/EMPLOYEE WAS STABLE. THE METHOD OF ACTIVATION USED BY THE HEALTH CARE PROFESSIONAL (HCP) WAS THE FINGER METHOD. THE NEEDLE WAS CONFIRMED TO BE SUCCESSFULLY ACTIVATED WITHIN THE SAFETY SHEATH, POST PATIENT INJECTION, IT CLICKED; HOWEVER, THE NEEDLE DID NOT GO IN IT. THE EVENT CAUSED A NEEDLE STICK. THERE WAS NO BLOOD LOSS OR ADDITIONAL TREATMENT REQUIRED. THE INJECTION WAS PERFORMED SUCCESSFULLY USING A SIMILAR DEVICE. THERE WAS NO FURTHER INFORMATION PROVIDED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 23347285 ↗
• MalfunctionSep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TERUMO MEDICAL RECEIVED INFORMATION THROUGH THE UNITED STATES FOOD AND DRUG ADMINISTRATION (FDA) MEDWATCH/DRUG QUALITY REPORTING SYSTEM (DQRS) REGARDING SUBLOCADE 100 MG, LOT #9246109US, WITH AN EXPIRATION DATE OF 30 APR 2026. THE REPORT DESCRIBED AN INJECTION SITE REACTION CHARACTERIZED AS ERYTHEMA. THIS WAS THE SECOND TIME THE PATIENT RECEIVED A SUBLOCADE INJECTION ADMINISTERED SUBCUTANEOUSLY IN THE ABDOMEN. THE FIRST INJECTION DID NOT RESULT IN ANY REACTION. HOWEVER, FOLLOWING THE SECOND INJECTION, THE PATIENT EXPERIENCED ERYTHEMA AT THE INJECTION SITE, DESCRIBED IN THE REPORT AS "ALMOST LIKE TICK BITE IN APPEARANCE." THE DOSE ADMINISTERED WAS 100 MG FROM LOT #G246109US, AND THE INJECTION WAS REPORTED TO HAVE BEEN ADMINISTERED PROPERLY. THE REPORT ALSO NOTED THAT A SECOND PATIENT EXPERIENCED THE SAME REACTION WITH THE SAME LOT NUMBER, AND A SEPARATE FILE WILL BE SUBMITTED FOR THAT CASE. ADDITIONAL INFORMATION WAS RECEIVED ON 14 AUG 2025 INDICATING THAT THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. TWO REACTION EVENTS HAVE BEEN REPORTED. IT HAS NOT BEEN CONFIRMED WHETHER THE PATIENT IS STABLE. INJECTION SITE REACTION WAS NOTED. THE INJECTIONS WERE ADMINISTERED. ESTIMATED BLOOD LOSS

  Patient problems: Administration Site Reaction

  MAUDE report 23023132 ↗
• MalfunctionSep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TERUMO MEDICAL RECEIVED INFORMATION THROUGH THE UNITED STATES FOOD AND DRUG ADMINISTRATION (FDA) MEDWATCH/DRUG QUALITY REPORTING SYSTEM (DQRS) REGARDING SUBLOCADE 100 MG, LOT #9246109US, WITH AN EXPIRATION DATE OF 30 APR 2026. THE REPORT DESCRIBED AN INJECTION SITE REACTION CHARACTERIZED AS ERYTHEMA. THIS WAS THE SECOND TIME THE PATIENT RECEIVED A SUBLOCADE INJECTION ADMINISTERED SUBCUTANEOUSLY IN THE ABDOMEN. THE FIRST INJECTION DID NOT RESULT IN ANY REACTION. HOWEVER, FOLLOWING THE SECOND INJECTION, THE PATIENT EXPERIENCED ERYTHEMA AT THE INJECTION SITE, DESCRIBED IN THE REPORT AS "ALMOST LIKE TICK BITE IN APPEARANCE." THE DOSE ADMINISTERED WAS 100 MG FROM LOT #G246109US, AND THE INJECTION WAS REPORTED TO HAVE BEEN ADMINISTERED PROPERLY. THE REPORT ALSO NOTED THAT A SECOND PATIENT EXPERIENCED THE SAME REACTION WITH THE SAME LOT NUMBER, AND A SEPARATE FILE WILL BE SUBMITTED FOR THAT CASE. ADDITIONAL INFORMATION WAS RECEIVED ON 14 AUG 2025 INDICATING THAT THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. TWO REACTION EVENTS HAVE BEEN REPORTED. IT HAS NOT BEEN CONFIRMED WHETHER THE PATIENT IS STABLE. INJECTION SITE REACTION WAS NOTED. THE INJECTIONS WERE ADMINISTERED. ESTIMATED BLOOD LOSS

  Patient problems: Administration Site Reaction

  MAUDE report 23023131 ↗
• MalfunctionAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT A PHARMACIST ADMINISTERED SUBLOCADE (BUPRENORPHINE EXTENDED-RELEASE INJECTION) 100 MG TO A PATIENT ON (B)(6) 2025. THIS WAS NOT THE PATIENT'S FIRST DOSE. IMMEDIATELY FOLLOWING THE INJECTION, WHICH WAS ADMINISTERED ON (B)(6) 2025, THE PATIENT DEVELOPED REDNESS IN THE ABDOMINAL AREA. THE REACTION WAS ASSOCIATED WITH LOT NUMBER 2C0812-RBP-600. THE PATIENT WAS TREATED WITH A TOPICAL CORTICOSTEROID CREAM. THE ESTIMATED BLOOD LOSS WAS NOT CONFIRMED. ADDITIONAL INFORMATION RECEIVED ON 24 JUL 2025: THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. IT IS NOT CONFIRMED WHETHER THE NEEDLE TIP WAS DAMAGED PRIOR TO USE.

  Patient problems: Administration Site Reaction

  MAUDE report 22868576 ↗
• MalfunctionAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT A PHARMACIST ADMINISTERED SUBLOCADE (BUPRENORPHINE EXTENDED-RELEASE INJECTION) 100 MG TO A PATIENT ON (B)(6) 2025. THIS WAS NOT THE PATIENT'S FIRST DOSE. IMMEDIATELY FOLLOWING THE INJECTION, WHICH WAS ADMINISTERED ON (B)(6) 2025, THE PATIENT DEVELOPED REDNESS IN THE ABDOMINAL AREA. THE REACTION WAS ASSOCIATED WITH LOT NUMBER 2C0812-RBP-600. THE PATIENT DID NOT RECEIVE TREATMENT FOR THE REACTION. THE ESTIMATED BLOOD LOSS WAS NOT CONFIRMED. ADDITIONAL INFORMATION RECEIVED ON 24 JUL 2025: THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. IT IS NOT CONFIRMED WHETHER THE NEEDLE TIP WAS DAMAGED PRIOR TO USE.

  Patient problems: Administration Site Reaction

  MAUDE report 22868567 ↗
• MalfunctionJul 31, 2025Activation Failure; Activation Failure

  THE USER FACILITY REPORTED THAT A NURSE STATED SUBLOCADE 100 MILLIGRAMS (LOT NUMBER: G24610945, EXPIRATION DATE: APRIL 30, 2026) WAS ADMINISTERED; HOWEVER, THE SAFETY LOCK FAILED, RESULTING IN THE NEEDLE PRICKING A MEDICAL PROVIDER. IT WAS NOTED THAT THIS WAS NOT THE FIRST TIME THE PROVIDER HAD ADMINISTERED SUBLOCADE. THE SYRINGE HAD ALREADY BEEN PLACED IN A SHARP'S CONTAINER, AND THEREFORE, PHOTOGRAPHS COULD NOT BE PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 07 JUL 2025: THE SAMPLE IS NOT AVAILABLE. THE CONDITION OF THE PATIENT IS UNKNOWN. IT IS ALSO UNKNOWN WHETHER TESTING HAS BEEN COMPLETED TO CLEAR THE PROVIDER FOR RETURN TO NORMAL DUTIES. THE METHOD OF ACTIVATION IS UNKNOWN, AND IT IS UNCLEAR WHETHER SUCCESSFUL ACTIVATION WITHIN THE SAFETY SHEATH WAS CONFIRMED FOLLOWING PATIENT INJECTION. IT IS UNKNOWN WHETHER THE EVENT RESULTED IN BLOOD LOSS.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22683663 ↗
• MalfunctionJul 25, 2025Connection Problem; Connection Problem

  THE USER FACILITY REPORTED THAT DURING THE PROCESS OF CLOSING THE SAFETY MECHANISM, THE NEEDLE DETACHED FROM THE SYRINGE AND PENETRATED THE PROVIDER'S FINGER. THE PROVIDER HAD COMPLETED THE INJECTION TO THE PATIENT PRIOR TO THE INCIDENT.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22608929 ↗
• MalfunctionMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT THE PATIENT HAD ALLERGIC REACTIONS AT THE INJECTION SITE AFTER SHE RECEIVED HER SHOT. THE SITE WAS VERY ITCHY, RED, AND HOT TO TOUCH. SHE PUT ICE ON IT AND THE NEXT DAY THE SWELLING AND REDNESS DID DECREASE. IT TOOK ABOUT THREE (3) DAYS TO GO AWAY.

  Patient problems: Administration Site Reaction; Skin Inflammation/ Irritation

  MAUDE report 22114381 ↗
• MalfunctionMay 30, 2025Break; Break

  THE USER FACILITY REPORTED THAT WHEN THE PATIENT WAS GIVEN HER SHOT, THE NEEDLE BROKE, AND THE MEDICATION SPRAYED ONTO THE PATIENT. SHE DID NOT RECEIVE ANY OF THE MEDICATION. INSURANCE WAS ABLE TO DO AN OVERRIDE AND ORDERED HER ANOTHER SHOT.

  Patient problems: Insufficient Information

  MAUDE report 22114380 ↗
• MalfunctionMar 17, 2025Activation Failure; Activation Failure

  THE USER FACILITY REPORTED THAT A NURSE EXPERIENCED A NEEDLE STICK INJURY WHILE ADMINISTERING SUBLOCADE. THE COVER GOT STUCK WHEN HE TRIED TO CLOSE IT, CAUSING HIS FINGER TO SLIP OVER THE END. THERE WAS NO BLOOD LOSS. THE EVENT OCCURRED INTRA-OPERATIVELY AND DID NOT RESULT IN PATIENT INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION.

  Patient problems: Needle Stick/Puncture

  MAUDE report 21625890 ↗
• MalfunctionJan 3, 2025Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT A SUBLOCADE 300 MILLIGRAM LONG-ACTING INJECTION (LIA) WAS ADMINISTERED TO A CLIENT WITH NO COMPLICATIONS. THE NEEDLE PROTECTOR CAP WAS APPLIED BY PRESSING IT GENTLY AGAINST A TABLE. THE NEEDLE BASE APPEARED TO CRACK OR BEND, RESULTING IN THE NEEDLE TURNING ROUGHLY 30 DEGREES FROM PARALLEL TO THE BARREL AND SLICING AN OPEN WOUND TO THE CREASE BETWEEN THE LEFT FOREFINGER DISTAL AND MIDDLE PHALANX. NO EXCESSIVE FORCE OR CARELESSNESS WAS INVOLVED, SUGGESTING A POSSIBLE FAULT IN THE NEEDLE MOUNT. ADDITIONAL INFORMATION RECEIVED ON DECEMBER 16, 2024: AFTER THE EVENT, THE SAFETY LATCH WAS ENGAGED ON THE NEEDLE, AND IT WAS DISPOSED OF IN A SHARP'S CONTAINER. IT WAS LATER RETRIEVED, AS IT WAS THOUGHT WISE TO HAVE IT AVAILABLE. THE DEVICE BELIEVED TO BE THE OFFENDING ONE WAS FISHED OUT. SINCE THE SAFETY LATCH IS NOW FIRMLY IN PLACE, THE NEEDLE CANNOT BE CLOSELY ASSESSED WITHOUT REMOVING THE SAFETY LATCH. A PHOTO OF THE SUSPECT DEVICE IS ATTACHED, BUT IT LOOKS NORMAL, AND THE CONDITION OF THE DEVICE WHERE IT IS HIDDEN BY THE SAFETY LATCH CANNOT BE ASSESSED. IT IS NOT ENTIRELY CERTAIN WHICH PART OF THE NEEDLE, OR ITS MOUNT CRACKED OR BENT. THERE IS A FAINT RECOL

  Patient problems: Laceration(s)

  MAUDE report 21072022 ↗
• MalfunctionNov 29, 2024Difficult or Delayed Activation; Difficult or Delayed Activation

  THE USER FACILITY REPORTED AN ISSUE CLOSING THE NEEDLE CAP. THE NURSE HAD DIFFICULTY CLOSING THE NEEDLE CAP AND USED THEIR FINGER, RESULTING IN A NEEDLE STICK INJURY.

  Patient problems: Needle Stick/Puncture

  MAUDE report 20808621 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT A 35-YEAR-OLD FEMALE RECEIVED A SUBLOCADE INJECTION ON (B)(6) 2024, AS REPORTED BY AN ADDICTION/INFECTIOUS DISEASE NURSE MANAGER. THE PATIENT RETURNED TO THE OFFICE ON (B)(6) 2024, WITH CELLULITIS AT THE INJECTION SITE. INCISION AND DRAINAGE (I&D) WERE PERFORMED, AND A WOUND CULTURE IDENTIFIED PANTOEA AGGLOMERANS, A BACTERIUM SOMETIMES FOUND IN CONTAMINATED MEDICAL SUPPLIES. ADDITIONAL INFORMATION WAS RECEIVED ON 30 AUG 2024: THE NURSE ADVISED THAT NO MEDICAL SUPPLIES WERE TESTED FOR CONTAMINATION.

  Patient problems: Cellulitis

  MAUDE report 20328437 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT A 35-YEAR-OLD FEMALE RECEIVED A SUBLOCADE INJECTION ON (B)(6) 2024, AS REPORTED BY AN ADDICTION/INFECTIOUS DISEASE NURSE MANAGER. THE PATIENT RETURNED TO THE OFFICE ON 6 AUG 2024, WITH CELLULITIS AT THE INJECTION SITE. INCISION AND DRAINAGE (I&D) WERE PERFORMED, AND A WOUND CULTURE IDENTIFIED PANTOEA AGGLOMERANS, A BACTERIUM SOMETIMES FOUND IN CONTAMINATED MEDICAL SUPPLIES. ADDITIONAL INFORMATION WAS RECEIVED ON 30 AUG 2024: THE NURSE ADVISED THAT NO MEDICAL SUPPLIES WERE TESTED FOR CONTAMINATION.

  Patient problems: Cellulitis

  MAUDE report 20328321 ↗
• MalfunctionJun 6, 2024Break; Break

  THE USER FACILITY REPORTED THAT THE INVOLVED NEEDLE DETACHED DURING THE INJECTION PROCESS. THE EVENT OCCURRED INTRA-OPERATIVE. THE PATIENT WAS NOT INJURED DURING THE EVENT AND MEDICAL/SURGICAL INTERVENTION WAS NOT NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 19480755 ↗
• MalfunctionApr 10, 2024Break; Break

  THE USER FACILITY REPORTED THAT THE INVOLVED NEEDLE WOULD NOT PUNCTURE VIAL WHICH CAUSED THE PRODUCT TO BREAK. THE PRODUCT WAS DAMAGED. THE EVENT OCCURRED INTRA-OPERATIVE. THE TYPE OF PROCEDURE PERFORMED WAS A SUBLOCADE INJECTION 100MG. ADDITIONAL INFORMATION WAS RECEIVED ON 12 MAR 2024: IT WAS REPORTED THAT WHILE APPLYING PRESSURE INTO THE VIAL THE NEEDLE BROKE. ADDITIONAL INFORMATION WAS RECEIVED ON 15 MAR 2024: THERE WAS DAMAGE NOTED TO THE NEEDLE UPON OPENING FOR USE. THE PATIENT DID NOT RECEIVE THEIR INJECTION AS INTENDED DESPITE THE ISSUE NOTED. THE FACILITY RECEIVED A REPLACEMENT AFTER THEY REPORTED THIS ISSUE. THE PATIENT IS STABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 18 MAR 2024: THE PATIENT DID NOT RECEIVE THE INJECTION FROM THE DAMAGED NEEDLE. THE PHARMACY REPLACED AND SENT A NEW PRODUCT TO THE FACILITY, AND THE PATIENT RECEIVED THAT INJECTION. THERE WERE NO CONCOMITANT DEVICES USED WITH THE SAFETY NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19079465 ↗
• MalfunctionApr 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT FOLLOWING ADMINISTRATION OF SUBLOCADE 300MG THE PATIENT DEVELOPED A SKIN INFECTION. THE DEVICE PROBLEM OCCURRED AFTER THE USE. THE INCIDENT HAS NOT LED TO A SERIOUS DETERIORATION IN THE STATE OF HEALTH TO THE PATIENT. THE EVENT WAS NOT CAUSED BY USER ERROR.

  Patient problems: Skin Infection

  MAUDE report 16767921 ↗
• MalfunctionApr 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT FOLLOWING ADMINISTRATION OF SUBLOCADE 300MG THE PATIENT DEVELOPED A SKIN INFECTION. THE DEVICE PROBLEM OCCURRED AFTER THE USE. THE INCIDENT HAS NOT LED TO A SERIOUS DETERIORATION IN THE STATE OF HEALTH TO THE PATIENT. THE EVENT WAS NOT CAUSED BY USER ERROR.

  Patient problems: Skin Infection

  MAUDE report 16767919 ↗