SURGUARD2 SG2+2238Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 14806017507081), received between Mar 19, 2020 and Oct 30, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY NURSE REPORTED A PRODUCT SAFETY CONCERN THAT WAS EXPERIENCED WITH THE INVOLVED TERUMO SURGUARD 2 SAFETY HYPODERMIC NEEDLE. THE SYRINGES COME PREFILLED WITH THE DEPO PROVERA CONTRACEPTIVE INJECTION. THE NEEDLE SAFETY CLASP FALLS COMPLETELY OFF THE DEVICE. THE PATIENT ADMINISTRATING THE INJECTION AND THE PATIENT RECEIVED THE INJECTION WERE NOT INJURED DURING THE EVENT AND MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THE EVENT OCCURRED INTRA-OPERATIVE. ADDITIONAL INFORMATION WAS RECEIVED ON 19 OCT 2023: THERE WAS NO VISIBLE DAMAGE TO THE DEVICE. THE PLASTIC PIECE ATTACHED TO THE NEEDLE ITSELF DID NOT COME OFF. IT WAS JUST THE OUTER CLASP THAT DETACHED FROM WHERE THE SAFETY CAP AND NEEDLE MEET AT THE BASE. THE INCIDENT HAPPENED WHEN TRIED TO ACTIVATE THE SAFETY AND INSTEAD IT FELL ONTO THE FLOOR. OVERUSE OF FORCE WAS NOT APPLIED WHEN THE SAFETY WAS ACTIVATED OR WHEN THE NEEDLE WAS ATTACHED TO THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18036226 ↗
• MalfunctionNov 14, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT TWO (2) TERUMO SURGUARD2 NEEDLES HAD A PERFORATION IN A BLISTER ON THE PRINTER SIDE WERE FOUND AFTER VISUALLY CHECKING (B)(4) NEEDLE POUCHES. THE FIRST PERFORATED BLISTER WAS INITIALLY FOUND DURING AN IN-PROCESS CONTROL (IPC) OF THE PACKED PRODUCT. THE SECOND PERFORATED BLISTER WAS FOUND DURING A SAMPLE TEST OF (B)(4) UNPROCESSED NEEDLE POUCHES. THE SAMPLE WAS RECEIVED ON (B)(6) 2022. BASED ON THE ACTUAL SAMPLE EVALUATION THE HOLE ON BLISTER AFFECTING STERILITY IS NOT VISIBLE TO THE USER HENCE, PROBABILITY OF USING UNSTERILE PRODUCT IS HIGH. THIS EVENT OCCURRED PRE-TREATMENT. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15794248 ↗
• MalfunctionNov 14, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT ONE PERFORATED BLISTER WAS FOUND DURING MANUAL INSERTION OF THE POUCHES INSIDE THE BLISTERS. THE SAMPLE WAS RECEIVED ON OCTOBER 24, 2022. BASED ON THE ACTUAL SAMPLE EVALUATION, THE HOLE ON THE BLISTER AFFECTING STERILITY WAS NOT VISIBLE TO THE USER THEREFORE THE PROBABILITY OF USING THIS UNSTERILIZED PRODUCT WAS HIGH. THIS EVENT OCCURRED PRE-TREATMENT. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15794162 ↗
• MalfunctionJul 29, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THE USER FACILITY REPORTED THAT DURING PRODUCTION ORDER NUMBER FF9561 NEEDLE POUCHES WERE MANUAL PLACED IN A BLISTER CAVITY. DURING THE MANUAL PROCESS, ONE POUCH WAS FOUND WITH A HOLE LEADING TO STERILITY LOSS. A SAMPLE SET OF 1250 WAS TAKEN, NO OTHER DEFECTS WERE FOUND. PRODUCTION HAS BEEN CONTINUED WITH INCREASED FOCUS ON THE INTEGRITY OF THE POUCHES AND ANOTHER DEFECT WAS FOUND. TWO DEFECTS IN TOTAL. AFTER DETECTION OF THE SECOND DEFECT, PRODUCTION HAS BEEN INTERRUPTED. THE RESIDUAL STOCK HAS BEEN BLOCKED FOR LOT NUMBER 210114B. THERE WAS NO PATIENT INVOLVEMENT. A BUBBLE LEAK TEST WAS CONDUCTED WHERE BLISTERS WERE FILLED WITH AIR AND SUBMERGED IN WATER. AIR BUBBLES ESCAPING FROM THE BLISTER IS AN INDICATION OF LEAKAGE. ONE OF THE 20 QUESTIONABLE BLISTERS OF BATCH 210114B HAS BEEN IDENTIFIED WITH LEAKAGE. THE HOLE IS IDENTIFIED, AND THE SIZE IS ESTIMATED TO BE AROUND 100-150 MICROMETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12247117 ↗
• MalfunctionMar 19, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THE USER FACILITY REPORTED THAT THEY HAD NEEDLE BLISTERS WITH DAMAGE AND HOLES IMPACTING STERILITY. THIS WAS OBSERVED DURING PACKAGING. THIS IS A PROCESSABLE DEFECT WITH POTENTIAL IMPACT ON THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 9853266 ↗