Monoject 1182515Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521544697), received between Nov 1, 2019 and Jul 28, 2025 — classified as 1 injury, 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2025Partial Blockage; Partial Blockage

  CUSTOMER REPORTED THAT WHEN BEING UTILIZED IT IS DIFFICULT TO PUSH MEDICATIONS THROUGH, AT TIMES UNABLE TO PUSH MEDICATIONS OR FEELS AS IF GETTING PUSH BACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628551 ↗
• MalfunctionMay 16, 2025Defective Component; Defective Component

  "CUSTOMER REPORTED: THE CUSTOMER REPORTED THAT THEY ARE EXPERIENCING RASHES ON THEIR PATIENTS, AS WELL AS ISSUES WITH THE SAFETY MECHANISM LOCKING.

  Patient problems: Rash

  MAUDE report 22035511 ↗
• MalfunctionDec 21, 2021Break; Break

  THE CUSTOMER REPORTED WET ACUPUNCTURE WAS BEING PERFORMED ON A SEDATED, VERY WELL-BEHAVED HORSE. ELEVEN NEEDLES WERE PLACED BY THE VETERINARIAN, AND THEY BEGAN TO INJECT THEM, AS IS NORMAL PROCEDURE. WHEN THEY WERE ABOUT FINISHED INJECTING ALL THE NEEDLES, THE HORSE MOVED 1 VERY SMALL STEP FORWARD, AS THEY OFTEN DO WITHOUT ANY PROBLEM. THE VET BEGAN REMOVING THE NEEDLES STARTING FROM THE FRONT AND HEADING BACKWARDS. THE FIRST NEEDLE BROKE IN HALF AS IT WAS SLOWLY PULLED OUT. THE NEXT ONE CAME OUT WITH DIFFICULTY, THE NEXT BROKE IN HALF AS IT WAS VERY CAUTIOUSLY PULLED OUT. THE REST DID NOT BREAK. THE AREA AROUND THE NEEDLE WAS CLIPPED AND AN ULTRASOUND WAS PERFORMED. THEY COULD SEE 1 NEEDLE BUT COULD NOT CONFIDENTLY MAKE OUT THE SECOND. THE OWNER GAVE PERMISSION FOR EMERGENCY EXPLORATORY SURGERY. REGIONAL ANESTHESIA WAS GIVEN TO THE HORSE, AND A LONG INCISION OVER AND BETWEEN WHERE THE 2 NEEDLES BROKE WAS MADE. AFTER ABOUT 5 MINUTES OF SEARCHING, 1 NEEDLE PIECE WAS LOCATED AND EXTRACTED WITH FORCEPS. DESPITE ANOTHER 30 - 45 MINUTES OF SEARCHING, THE 2ND NEEDLE WAS NOT LOCATED. THE HORSE WAS PRESCRIBED BANAMINE FOR A FEW DAYS BECAUSE OF THE AMOUNT OF EXPLORATION. THE VETERINARIAN WI

  Patient problems: Device Embedded In Tissue or Plaque; Laceration(s)

  MAUDE report 13051959 ↗
• MalfunctionNov 28, 2019Break; Difficult to Remove

  CUSTOMER REPORTED THAT THE SAFETY NEEDLE BROKE OFF IN A PATIENT'S BACK WHILE RECEIVING A TRIGGER POINT INJECTION ON (B)(6) 2019 IN AMBULATORY CARE. THE PATIENT WAS TRANSFERRED TO THE EMERGENCY DEPARTMENT. GENERAL SURGERY [HEALTH PROFESSIONAL] THEN ATTEMPTED UNDER FLUOROSCOPY TO PERFORM AN I&D TO TRY TO REMOVE THE NEEDLE. AT THE TIME OF THE REPORT, THE PATIENT WAS WAITING IN THE OPERATING ROOM, AS C-CASE EMERGENCY SURGERY TO REMOVE THIS FOREIGN BODY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9390397 ↗
• InjuryNov 1, 2019Break; Break

  THE CUSTOMER REPORTED THAT THE NEEDLE BROKE OFF IN THE PATIENT'S BACK WHILE A TRIGGER POINT INJECTION WAS BEING DONE IN AMBULATORY CARE. THE PATIENT WAS TRANSFERRED TO THE EMERGENCY DEPARTMENT. GENERAL SURGERY WAS ATTEMPTED UNDER FLUOROSCOPY TO TRY TO REMOVE THE NEEDLE. THE NEEDLE WAS NOT REMOVED AND THE PATIENT, WITH THE NEEDLE STILL IN HIS BACK, WAS SENT HOME ON PAIN MEDICATION. THE SURGEON AND THE ANESTHESIOLOGIST HAD DECIDED TO WAIT UNTIL THE PATIENT RECOVERS FROM THE EXPLORING THAT THEY DID TO TRY TO FIND THE NEEDLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 9267323 ↗