SURGUARD3 SG3+1816Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 14806017510708), received between Apr 25, 2024 and Oct 17, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2024Break; Break

  THE USER FACILITY DURING THE ADMINISTRATION OF PERSERIS 120MG AT THE INPATIENT SITE, THE INVOLVED NEEDLE BROKE OFF IN THE PATIENT'S ARM. ALL PACKAGING WAS DISPOSED. ADDITIONAL INFORMATION WAS RECEIVED ON 18 SEPT 2024: THE PHARMACIST REPORTS THAT PERSERIS 120MG WAS ADMINISTERED ON (B)(6) 2024. THE INJECTION SITE WAS BLEEDING, SO IT WAS WRAPPED. MORE THAN 24 HOURS LATER, A PIECE OF THE NEEDLE WAS FOUND STILL IN THE PATIENT'S ARM. A CT SCAN ON (B)(6) 2024 CONFIRMED THE PRESENCE OF THE NEEDLE IN THE ARM. IT WAS NOT CONFIRMED IF THE PATIENT RECEIVED THE FULL DOSE BUT BELIEVES IT WAS ADMINISTERED ON (B)(6) 2024.

  Patient problems: Foreign Body In Patient

  MAUDE report 20478204 ↗
• MalfunctionSep 13, 2024Activation Problem; Activation Problem

  THE USER FACILITY REPORTED THAT THE HEALTHCARE PROVIDER WAS DISTRACTED DURING THE NEEDLE LOCKING PROCESS, CAUSING IT TO SLIP. CONSEQUENTLY, THE PROVIDER'S LEFT POINTER FINGER WAS CUT BY THE NEEDLE FOLLOWING THE ADMINISTRATION OF SUBLOCADE TO AN HIV POSITIVE PATIENT. THE PROVIDER REMARKED THAT THE LOCKING SYSTEM WAS TOO TIGHT. THE REPORTED INCIDENT DID NOT RESULT IN PATIENT INJURY OR MEDICAL OR SURGICAL INTERVENTION.

  Patient problems: Needle Stick/Puncture

  MAUDE report 20211792 ↗
• MalfunctionMay 8, 2024Break; Break

  THE PATIENT (USER) REPORTED THAT THE INVOLVED NEEDLE BROKE, AND THE MEDICATION IS EXPIRED. IT WAS REPORTED THAT THE PERSERIS MEDICATION WAS MIXED AND SAT OUT TOO LONG. THEREFORE, IT WAS DISCARDED TO PREVENT THE RISK OF GIVING EXPIRED MEDICATION. THE USER ALSO EXPLAINED THAT THE NEEDLE ALSO SNAPPED, AND THERE WAS NO WAY TO PUT IT BACK ON THE MEDICATION. THE USER STATED THE PERSERIS 90 MG WAS SHIPPED TO ON 19 MAR 2024, AND THE PERSERIS 90 MG WAS MIXED ON 03 APR 2024 AND PLACED BACK IN THE REFRIGERATOR. THE USER DID NOT HAVE STORAGE INFORMATION AND DISCARDED THE MEDICATION ON THE EVENING OF 03 APR 2024. THE USER CONFIRMED THAT THE SAFETY CAP WAS ON THE NEEDLE, HOWEVER WHEN SHE ATTEMPTED TO REMOVE IT, IS WHEN THE NEEDLE ITSELF SNAPPED IN HALF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19266207 ↗
• MalfunctionApr 25, 2024Break; Use of Device Problem; Break; Use of Device Problem

  THE USER FACILITY REPORTED THAT A PATIENT ADMITTED THAT THE NEEDLE BROKE WHILE IN THE PROCESS OF PREPARATION AS IT WAS NOT BROKEN WHEN THE BOX WAS OPENED. ANOTHER 12-GAUGE NEEDLE WAS PLANNED TO BE USED. THE HEALTH CARE PROVIDER (HCP) IS AWARE THAT OF SELF-ADMINISTERING THE MEDICATION. THE EVENT OCCURRED INTRA-OPERATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19188811 ↗