SURGUARD3 SG3-2525Recalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 34806017508204), received between Nov 29, 2017 and Aug 28, 2026 — classified as 71 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (37 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 25 most recent of 71 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50497499 ↗
• MalfunctionAug 28, 2026Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50497498 ↗
• MalfunctionAug 28, 2026Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50497496 ↗
• MalfunctionAug 28, 2026Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50497416 ↗
• MalfunctionApr 2, 2026Malposition of Device

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT WHEN CLOSING THE SAFETY ON A NEEDLE AFTER GIVING AN INJECTION THE BASE CLICKED IN, BUT THE TIP WOULD NOT, LEAVING THE NEEDLE TIP EXPOSED. THE NEEDLE WAS SAFELY DISPOSED OF IN SHARPS CONTAINER. THERE WERE NO PATIENT HARM AND NO BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 16-MAR-2026: THE INJECTION BEING GIVEN AT THE TIME OF THE EVENT WAS A VACCINE, PCV20. THE INJECTION WAS ABLE TO BE GIVEN SUCCESSFULLY. THERE WERE NO NEEDLESTICKS DUE TO THE EVENT. THE METHOD OF ACTIVATION USED WAS HARD SURFACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24769701 ↗
• MalfunctionMar 10, 2026Malposition of Device

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE DEFECT WAS IN THE SAFETY LOCKING MECHANISM. THE NEEDLE TIP CAN REMAIN EXPOSED EVEN AFTER ATTEMPTING TO LOCK IT, WHICH POSED A SIGNIFICANT RISK FOR ACCIDENTAL NEEDLE STICKS. NO INJURIES OR BLOOD LOSS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24560169 ↗
• MalfunctionFeb 12, 2026Malposition of Device

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE CAP WOULD NOT GO BACK ON THE NEEDLE. ADDITIONAL INFORMATION WAS RECEIVED ON 30JAN2026: THE EVENT WAS INITIALLY NOTIFIED ON (B)(6) 2025. THE PRODUCT WAS USED DURING THE NEEDLE SAFETY TRAINING WITH A DETAILED EXPLANATION OF HOW THE PRODUCT FUNCTIONS. THE STAFF WAS PROVIDED WITH AT LEAST 2 SAMPLES TO DEMONSTRATE THE USE OF THE PRODUCT USING HARD SURFACE ACTIVATION AND THUMB ACTIVATION AND THEN HAVE THE STAFF RETURN TO DEMONSTRATE. IF NOT SATISFIED WITH RETURN DEMONSTRATION, TRAINING IS REPEATED. NEEDLE STICK OCCURRED. BLOOD LOSS IS VERY MINIMAL. LAB WORK WAS COLLECTED FROM THE PATIENT.

  Patient problems: Needle Stick/Puncture

  MAUDE report 24329701 ↗
• MalfunctionFeb 2, 2026Activation Failure

  TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT # (B)(4). THE MEDWATCH EVENT DESCRIPTION STATED THAT: " MULTIPLE SYRINGE AND NEEDLE FAILURES WERE REPORTED BY NURSES AT VARIOUS CLINICS DURING FLU VACCINATIONS. HIGH DOSE FLU VACCINE PRE-FILLED SYRINGES (LOT NUMBER 409166) EXPERIENCED ISSUES: NEEDLES FELL OFF SYRINGES BEFORE SAFETY DEPLOYMENT AND DURING THE CAPPING PROCESS. TERUMO 25-GAUGE 1-INCH NEEDLES (250312E) DISPLAYED RECURRING SAFETY DEVICE FAILURES: NEEDLES DID NOT ENGAGE WITH THE SAFETY MECHANISM PROPERLY AND REMAINED ON THE SYRINGE. THE SYRINGE WAS USED AS INTENDED. THE DEVICE WAS HARD TO USE. THERAPIES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT: NOT APPLICABLE;"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24242826 ↗
• MalfunctionFeb 2, 2026Activation Failure

  TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT # (B)(4). THE MEDWATCH EVENT DESCRIPTION STATED THAT: " MULTIPLE SYRINGE AND NEEDLE FAILURES WERE REPORTED BY NURSES AT VARIOUS CLINICS DURING FLU VACCINATIONS. HIGH DOSE FLU VACCINE PRE-FILLED SYRINGES (LOT NUMBER 409166) EXPERIENCED ISSUES: NEEDLES FELL OFF SYRINGES BEFORE SAFETY DEPLOYMENT AND DURING THE CAPPING PROCESS. TERUMO 25-GAUGE 1-INCH NEEDLES (250312E) DISPLAYED RECURRING SAFETY DEVICE FAILURES: NEEDLES DID NOT ENGAGE WITH THE SAFETY MECHANISM PROPERLY AND REMAINED ON THE SYRINGE. THE SYRINGE WAS USED AS INTENDED. THE DEVICE WAS HARD TO USE. THERAPIES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT: NOT APPLICABLE;"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24242808 ↗
• MalfunctionFeb 2, 2026Malposition of Device

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE CAP WOULD NOT GO BACK ON THE NEEDLE. ADDITIONAL INFORMATION WAS RECEIVED ON 08JAN2026: THERE WAS A DEFECT IN THE SAFETY LOCKING MECHANISM. THE NEEDLE TIP CAN REMAIN EXPOSED EVEN AFTER ATTEMPTING TO LOCK IT, WHICH POSES A SIGNIFICANT RISK FOR ACCIDENTAL NEEDLE STICKS. ADDITIONAL INFORMATION WAS RECEIVED ON 09JAN2026: THE EVENT WAS INITIALLY NOTIFIED ON 09/01/25. THE PRODUCT WAS USED DURING THE NEEDLE SAFETY TRAINING WITH A DETAILED EXPLANATION OF HOW THE PRODUCT FUNCTIONS. THE STAFF WAS PROVIDED WITH AT LEAST 2 SAMPLES TO DEMONSTRATE THE USE OF THE PRODUCT USING HARD SURFACE ACTIVATION AND THUMB ACTIVATION AND THEN HAVE THE STAFF RETURN TO DEMONSTRATE. IF NOT SATISFIED WITH RETURN DEMONSTRATION, TRAINING IS REPEATED. NEEDLE STICK OCCURRED. BLOOD LOSS IS VERY MINIMAL. LAB WORK WAS COLLECTED FROM THE PATIENT.

  Patient problems: Needle Stick/Puncture

  MAUDE report 24242771 ↗
• MalfunctionJan 16, 2026Activation Failure

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. A NEEDLE STICK/INJURY OCCURRED DUE TO THE SAFETY NOT WORKING PROPERLY. NO BLOOD LOSS WAS REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 24093892 ↗
• MalfunctionJan 16, 2026Activation Failure

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. A NEEDLE STICK/INJURY OCCURRED DUE TO THE SAFETY NOT WORKING PROPERLY. NO BLOOD LOSS WAS REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 24093891 ↗
• MalfunctionJan 13, 2026Activation Failure

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE SAFETY COVER DID NOT FULLY ENGAGE AFTER THE NEEDLE WAS PLACED DOWN AFTER THE INJECTION WAS ADMINISTERED. PUNCTURED SKIN THROUGH THE GLOVE. ADDITIONAL INFORMATION WAS RECEIVED ON 26DEC2025: THE PATIENT RECEIVED THE VACCINE AS INTENDED. THE STAFF MEMBER FOLLOWED UP AT BMC OCCUPATIONAL HEALTH. THERE WAS NO IMPACT ON THE PATIENT'S HEALTH. ADDITIONAL INFORMATION WAS RECEIVED ON 06JAN2026: THE ACTIVATION WAS ON A HARD SURFACE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 24052742 ↗
• MalfunctionDec 16, 2025Malposition of Device; Malposition of Device

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. THE TIP OF THE NEEDLE WAS EXPOSED. ADDITIONAL INFORMATION WAS RECEIVED ON 21NOV2025: IT WAS ACTIVATED BY APPLYING PRESSURE AGAINST THE TABLETOP IN THE PATIENT ROOM. NO NEEDLESTICK OCCURRED. THE NURSE DID NOT HEAR THE "CLICK" SOUND; THEREFORE, IT WAS VISUALLY INSPECTED AFTER ENGAGING THE SAFETY AND IT WAS NOTICED THAT THE TIP OF THE NEEDLE WAS EXPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816684 ↗
• MalfunctionNov 21, 2025Malposition of Device; Malposition of Device

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE NEEDLE BROKE AND STICK THE STAFF. THE NEEDLE WAS BREAKING AT THE WHITE CORE THAT IS ATTACHED TO THE ORANGE PART OF THE DEVICE. ADDITIONAL INFORMATION WAS RECEIVED ON 31OCT2025: WHEN THE EMPLOYEE WAS PUTTING THE SAFETY GUARD ON, THE NEEDLE SLIPPED OFF. THE EMPLOYEE WENT TO URGENT CARE FOR BLOOD TESTING. IT WAS UNKNOWN IF THERE WAS ANY BLOOD LOSS. THE EMPLOYEE WAS STABLE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 23617722 ↗
• MalfunctionNov 21, 2025Malposition of Device; Malposition of Device

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE NEEDLE BROKE AND STICK THE STAFF. THE NEEDLE WAS BREAKING AT THE WHITE CORE THAT IS ATTACHED TO THE ORANGE PART OF THE DEVICE. ADDITIONAL INFORMATION WAS RECEIVED ON 31OCT2025: THE STAFF MEMBER WAS ACTIVATING THE NEEDLE ON THE TABLE. THE EMPLOYEE DECLINED TREATMENT. THERE WAS A SMALL AMOUNT OF BLOOD NOTED. THE EMPLOYEE WAS STABLE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 23617721 ↗
• MalfunctionNov 18, 2025Malposition of Device; Malposition of Device

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE NEEDLE WAS NOT GOING INTO THE SAFETY MECHANISM AND WAS BENDING OUT. ADDITIONAL INFORMATION WAS RECEIVED ON 28OCT2025: THE NEEDLE FAILED TO FULLY ENTER SAFETY MECHANISM WHEN MECHANISM WAS ACTIVATED. THE NEEDLE CONTINUED TO STICK OUT PAST THE SAFETY SHIELD, POSING A RISK FOR NEEDLE STICK INJURY. THE PATIENT WAS PRESENT, AND THE PATIENT RECEIVED THE FLU VACCINATION. THERE WAS NO NEEDLE STICK INJURY THAT OCCURRED FROM THE DEVICE ISSUE. ESTIMATED BLOOD LOSS NOT APPLICABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 03NOV2025: THE NURSE WAS USING THE HARD SURFACE ACTIVATION METHOD. THE NEEDLE (ASSEMBLY) STAYED ON THE SYRINGE WHEN THE NEEDLE BENT OUTSIDE THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23580581 ↗
• MalfunctionNov 18, 2025Malposition of Device; Malposition of Device

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE NEEDLE WAS NOT GOING INTO THE SAFETY MECHANISM AND WAS BENDING OUT. ADDITIONAL INFORMATION WAS RECEIVED ON 28OCT2025: THE NEEDLE FAILED TO FULLY ENTER SAFETY MECHANISM WHEN MECHANISM WAS ACTIVATED. THE NEEDLE CONTINUED TO STICK OUT PAST THE SAFETY SHIELD, POSING A RISK FOR NEEDLE STICK INJURY. THE PATIENT WAS PRESENT, AND THE PATIENT RECEIVED THE FLU VACCINATION. THERE WAS NO NEEDLE STICK INJURY THAT OCCURRED FROM THE DEVICE ISSUE. ESTIMATED BLOOD LOSS NOT APPLICABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 03NOV2025: THE NURSE WAS USING THE HARD SURFACE ACTIVATION METHOD. THE NEEDLE (ASSEMBLY) STAYED ON THE SYRINGE WHEN THE NEEDLE BENT OUTSIDE THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23580580 ↗
• MalfunctionNov 18, 2025Malposition of Device; Malposition of Device

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE NEEDLE WAS NOT GOING INTO THE SAFETY MECHANISM, THE NEEDLE STAYED ON THE SYRINGE. ADDITIONAL INFORMATION WAS RECEIVED ON 28OCT2025: THE NEEDLE FAILED TO FULLY ENTER SAFETY MECHANISM WHEN MECHANISM WAS ACTIVATED. THE NEEDLE CONTINUED TO STICK OUT PAST THE SAFETY SHIELD, POSING A RISK FOR NEEDLE STICK INJURY. THE PATIENT WAS PRESENT, AND THE PATIENT RECEIVED THE FLU VACCINATION. THERE WAS NO NEEDLE STICK INJURY THAT OCCURRED FROM THE DEVICE ISSUE. ESTIMATED BLOOD LOSS NOT APPLICABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 03NOV2025: THE NURSE WAS USING THE HARD SURFACE ACTIVATION METHOD. THE NEEDLE (ASSEMBLY) STAYED ON THE SYRINGE WHEN THE NEEDLE BENT OUTSIDE THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23580570 ↗
• MalfunctionNov 18, 2025Malposition of Device; Malposition of Device

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE NEEDLE WAS NOT GOING INTO THE SAFETY MECHANISM; THE NEEDLE STAYED ON THE SYRINGE. ADDITIONAL INFORMATION WAS RECEIVED ON 28OCT2025: THE NEEDLE FAILED TO FULLY ENTER SAFETY MECHANISM WHEN MECHANISM WAS ACTIVATED. THE NEEDLE CONTINUED TO STICK OUT PAST THE SAFETY SHIELD, POSING A RISK FOR NEEDLE STICK INJURY. THE PATIENT WAS PRESENT, AND THE PATIENT RECEIVED THE FLU VACCINATION. THERE WAS NO NEEDLE STICK INJURY THAT OCCURRED FROM THE DEVICE ISSUE. ESTIMATED BLOOD LOSS NOT APPLICABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 03NOV2025: THE NURSE WAS USING THE HARD SURFACE ACTIVATION METHOD. THE NEEDLE (ASSEMBLY) STAYED ON THE SYRINGE WHEN THE NEEDLE BENT OUTSIDE THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23580565 ↗
• MalfunctionNov 18, 2025Malposition of Device; Malposition of Device

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE NEEDLE WAS NOT GOING INTO THE SAFETY MECHANISM, THE NEEDLE STAYED ON THE SYRINGE. ADDITIONAL INFORMATION WAS RECEIVED ON 28OCT2025: THE NEEDLE FAILED TO FULLY ENTER SAFETY MECHANISM WHEN MECHANISM WAS ACTIVATED. THE NEEDLE CONTINUED TO STICK OUT PAST THE SAFETY SHIELD, POSING A RISK FOR NEEDLE STICK INJURY. THE PATIENT WAS PRESENT, AND THE PATIENT RECEIVED THE FLU VACCINATION. THERE WAS NO NEEDLE STICK INJURY THAT OCCURRED FROM THE DEVICE ISSUE. ESTIMATED BLOOD LOSS NOT APPLICABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 03NOV2025: THE NURSE WAS USING THE HARD SURFACE ACTIVATION METHOD. THE NEEDLE (ASSEMBLY) STAYED ON THE SYRINGE WHEN THE NEEDLE BENT OUTSIDE THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23580564 ↗
• MalfunctionNov 18, 2025Malposition of Device; Malposition of Device

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE NEEDLE WAS NOT GOING INTO THE SAFETY MECHANISM, THE NEEDLE STAYED ON THE SYRINGE. ADDITIONAL INFORMATION WAS RECEIVED ON 28OCT2025: THE NEEDLE FAILED TO FULLY ENTER SAFETY MECHANISM WHEN MECHANISM WAS ACTIVATED. THE NEEDLE CONTINUED TO STICK OUT PAST THE SAFETY SHIELD, POSING A RISK FOR NEEDLE STICK INJURY. THE PATIENT WAS PRESENT, AND THE PATIENT RECEIVED THE FLU VACCINATION. THERE WAS NO NEEDLE STICK INJURY THAT OCCURRED FROM THE DEVICE ISSUE. ESTIMATED BLOOD LOSS NOT APPLICABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 03NOV2025: THE NURSE WAS USING THE HARD SURFACE ACTIVATION METHOD. THE NEEDLE (ASSEMBLY) STAYED ON THE SYRINGE WHEN THE NEEDLE BENT OUTSIDE THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23580563 ↗
• MalfunctionNov 18, 2025Malposition of Device; Malposition of Device

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE NEEDLE WAS NOT GOING INTO THE SAFETY MECHANISM; THE NEEDLE STAYED ON THE SYRINGE. ADDITIONAL INFORMATION WAS RECEIVED ON 28OCT2025: THE NEEDLE FAILED TO FULLY ENTER SAFETY MECHANISM WHEN MECHANISM WAS ACTIVATED. THE NEEDLE CONTINUED TO STICK OUT PAST THE SAFETY SHIELD, POSING A RISK FOR NEEDLE STICK INJURY. THE PATIENT WAS PRESENT, AND THE PATIENT RECEIVED THE FLU VACCINATION. THERE WAS NO NEEDLE STICK INJURY THAT OCCURRED FROM THE DEVICE ISSUE. ESTIMATED BLOOD LOSS NOT APPLICABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 03NOV2025: THE NURSE WAS USING THE HARD SURFACE ACTIVATION METHOD. THE NEEDLE (ASSEMBLY) STAYED ON THE SYRINGE WHEN THE NEEDLE BENT OUTSIDE THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23580562 ↗
• MalfunctionSep 12, 2025Malposition of Device; Malposition of Device

  TERUMO MEDICAL RECEIVED REPORTED INFORMATION INDICATING THAT THE SAFETY MECHANISM FAILED TO ACTIVATE PROPERLY AFTER USE, RESULTING IN THE NEEDLE BENDING AND REMAINING EXPOSED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2025 STATED THAT THE PROCEDURE INVOLVED VACCINE ADMINISTRATION TO A PEDIATRIC PATIENT. DURING ACTIVATION OF THE SAFETY SHEATH AGAINST A HARD EXAM TRAY, THE NEEDLE BENT AND WAS ONLY PARTIALLY CAPTURED INSIDE THE SHEATH, LEAVING THE TIP EXPOSED. A NEEDLE STICK INJURY OCCURRED, RESULTING IN STAFF EXPOSURE TO THE NEEDLE TIP. THE AFFECTED STAFF MEMBER REQUIRED LABORATORY TESTING FOR POTENTIAL EXPOSURE TO BLOODBORNE PATHOGENS AND WAS ABLE TO RETURN TO NORMAL DUTIES FOLLOWING THE INCIDENT. THE PEDIATRIC PATIENT WAS NOT INJURED. THE CONCOMITANT DEVICE USED WAS A PREFILLED SYRINGE CONTAINING THE VACCINE COMPONENTS.

  Patient problems: Needle Stick/Puncture

  MAUDE report 23035815 ↗
• MalfunctionFeb 19, 2025Malposition of Device; Malposition of Device

  THE USER FACILITY REPORTED THE NEEDLE DETACHED FROM THE PREFILLED SYRINGE AND REMAINED ON THE PATIENT WITHOUT THE SAFETY BEING ENGAGED. WE HAVE SINCE ADVISED THEM TO ENSURE THE NEEDLE IS SCREWED IN ALL THE WAY AND TO INFORM US IF THEY ENCOUNTER ANY OTHER ISSUES, TO DETERMINE IF IT IS USER ERROR. ADDITIONAL INFORMATION WAS RECEIVED ON 07 NOV 2024: THE REPORT WAS NEEDLE WAS BENT WHEN THE SAFETY WAS APPLIED AND THE SAFETY COULD NO LONGER FUNCTION APPROPRIATELY. THE ISSUE WAS FOUND AFTER USE WHILE APPLYING SAFETY. ADDITIONAL INFORMATION WAS RECEIVED ON 20 JAN 2025: THE DETAILS INDICATE THAT THE NEEDLE WAS BENT BY THE SAFETY MECHANISM. THE NEEDLE WAS ATTACHED TO A PREFILLED VACCINE SYRINGE. THIS INCIDENT OCCURRED AFTER THE ADMINISTRATION WAS COMPLETED. THERE WAS NO BLOOD LOSS AND NO REPORTED EVENT RESULTING IN PATIENT INJURY OR REQUIRING MEDICAL OR SURGICAL INTERVENTION. THERE IS NO DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY OR NECESSITATED MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21415060 ↗