Monoject 1182215Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521544659), received between Nov 13, 2019 and Jun 17, 2025 — classified as 2 injuries, 5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTED THAT THEIR PA WAS INJECTING LIDOCAINE AND WAS SPRAYED IN THE EYE. HE STATES IT WAS COMING OUT THE SIDES AND THAT THERE WAS A HOLE IN THE PLASTIC NEEDLE CONNECTION. THE PA SAID HE WAS ATTEMPTING A TENDON SHEATH INJECTION WHEN THE MEDICATION SPRAYED OUT THE SIDE OF THE PLASTIC HUB-NEEDLE CONNECTION. HE CONFIRMED NEEDLE WAS TWISTED ON TIGHTLY AND ATTEMPTED INJECTION AGAIN AND IT CONTINUED TO SPRAY OUT THE SIDES OF THE HUB, SPRAYING THE PA AND THE PATIENT. INJECTION ABORTED. GAUZE HELD TO PUNCTURE SITE TO OBTAIN HAEMOSTASIS. NEW INJECTION DREW UP AND USED A 25-GAUGE NEEDLE FROM A DIFFERENT LOT # TO PROCEED WITH THE INJECTION SAFELY. NO PATIENT HARM NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22226602 ↗
• MalfunctionNov 1, 2023Break; Fail-Safe Problem; Break; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT THE NEEDLE BROKE WHILE TRYING TO ENGAGE THE SAFETY MECHANISM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18052460 ↗
• MalfunctionNov 1, 2023Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THE SAFETY MECHANISM BENDING TO THE SIDE INSTEAD OF CAPTURING THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18052401 ↗
• MalfunctionJun 29, 2022Material Puncture/Hole; Material Puncture/Hole

  THE CUSTOMER REPORTED THAT THE NEEDLE IS WEAKENING AS THERE IS A HOLE NEAR THE SAFETY. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022, THE STAFF EXPLAINED THAT THE NEEDLE WAS UNDER PRESSURE WHEN IT STARTED ¿SQUIRTING NARCOTIC OUT THE SIDE OF THE NEEDLE HUB¿ THEY WERE LOOKING FOR THE HOLE AND TOOK THE SAFETY DEVICE OFF IN ORDER TO FIND THE HOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14859224 ↗
• InjuryMar 8, 2021Break; Entrapment of Device

  THE END USER DESCRIBED THAT ON (B)(6) 2020, IN THEIR SURGICAL DEPARTMENT A PATIENT WAS SCHEDULED FOR OPEN RIGHT INGUINAL HERNIA REPAIR FOR AN INCARCERATED RIGHT INGUINAL HERNIA. THE PATIENT HAD THE MONOJECT NEEDLE USED TO INJECT MEDICATION FOR POST SURGICAL NERVE BLOCK IN PATIENT'S RIGHT LOWER ABDOMEN. DURING INJECTING THE MEDICATION, THE NEEDLE BROKE OFF AT THE HUB AND REQUIRED EXTENSIVE EXPLORATION OF THE ABDOMEN TO LOCATE AND REMOVE THE BROKEN NEEDLE SEGMENT. ON (B)(6) 2021, THE PATIENT WAS ADMITTED TO THEIR SURGICAL DEPARTMENT FOR WOUND INFECTION AT RIGHT LOWER ABDOMEN. HEMATOMA EVACUATION, INCISION AND DRAINAGE OF WOUND ABSCESS WERE PERFORMED AND THE WOUND VAC PLACEMENT WAS APPLIED. THE PATIENT REQUIRED OBSERVATION ADMISSION WITH EXTENDED STAY AND WAS PLACED AS INPATIENT DUE TO LEVEL OF CARE NEEDED. ON (B)(6) 2021. THE PATIENT WAS PLACED IN SWING BED CARE DUE TO EXTENDED WOUND CARE. ON (B)(6) 2021. THE PATIENT WAS DISCHARGED HOME WITH HOME HEALTH. CURRENTLY, THE PATIENT CONTINUES WITH HOME HEALTH CARE FOR WOUND CARE. THE PATIENT IS STILL UNDER CARE OF SURGEON AND HOME HEALTH. THE CUSTOMER FURTHER STATED THAT AN ESTIMATED DISCHARGE TIME IS UNKNOWN.

  Patient problems: Abscess; Foreign Body In Patient; Hematoma; Post Operative Wound Infection

  MAUDE report 11440450 ↗
• InjuryFeb 12, 2021Break; Break

  THE CUSTOMER REPORTED THAT ON (B)(6) 2020, IN THEIR SURGICAL DEPARTMENT A PATIENT WAS SCHEDULED FOR OPEN RIGHT INGUINAL HERNIA REPAIR FOR AN INCARCERATED RIGHT INGUINAL HERNIA. THE PATIENT HAD THE MONOJECT NEEDLE USED TO INJECT MEDICATION FOR POST-SURGICAL NERVE BLOCK IN PATIENT¿S RIGHT LOWER ABDOMEN. DURING INJECTING THE MEDICATION, THE NEEDLE BROKE OFF AT THE HUB AND REQUIRED EXTENSIVE EXPLORATION TO LOCATE AND REMOVE THE NEEDLE SEGMENT. ON (B)(6) 2021, THE PATIENT WAS ADMITTED TO THEIR SURGICAL DEPARTMENT FOR WOUND INFECTION AT RIGHT LOWER ABDOMEN. HEMATOMA EVACUATION, INCISION AND DRAINAGE OF WOUND ABSCESS AND WOUND VAC PLACEMENT WERE PERFORMED. THE PATIENT REQUIRED OBSERVATION ADMISSION WITH EXTENDED STAY AND WAS PLACED AS IN-PATIENT (IP) DUE TO LEVEL OF CARE NEEDED. ON (B)(6) 2021, THE PATIENT WAS PLACED IN SWING BED CARE DUE TO EXTENDED WOUND CARE. ON (B)(6) 2021, THE PATIENT WAS DISCHARGED HOME WITH HOME HEALTH. CURRENTLY, THE PATIENT CONTINUES WITH HOME HEALTH CARE FOR WOUND CARE. THE PATIENT IS STILL UNDER CARE OF SURGEON AND HOME HEALTH. THE CUSTOMER FURTHER STATED THAT AN ESTIMATED DISCHARGE TIME IS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND IT W

  Patient problems: Abscess; Foreign Body In Patient; Hematoma; Post Operative Wound Infection

  MAUDE report 11321387 ↗
• MalfunctionNov 13, 2019Material Puncture/Hole; Fail-Safe Problem; Material Puncture/Hole; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT THE NEEDLE PUNCTURED THROUGH THE SAFETY MECHANISM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9316018 ↗