Monoject 11811022Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521544826), received between Jun 28, 2018 and Jul 28, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Defective Component” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2025Defective Component; Defective Component

  CUSTOMER REPORTED THAT THEIR CURRENT BLUNT TIP NEEDLE IS CORING THE RUBBER TOPS OF MEDICATION VIALS LEAVING A PIECE OF RUBBER IN THE MEDICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628536 ↗
• MalfunctionJul 9, 2025Defective Component; Defective Component

  CUSTOMER REPORTED THAT STAFF ARE EXPERIENCING CORING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22456237 ↗
• MalfunctionJul 2, 2025Defective Component; Defective Component

  CUSTOMER REPORTED THAT WHILE PREPARING AN INJECTABLE LOCAL ANAESTHETIC FOR A SUB TENON BLOCK, THEY DREW UP 10CC OF 0.75% BUPIVACAINE. UPON INSPECTION, THEY NOTICED A GRAY PARTICULATE MATERIAL FLOATING IN THE SYRINGE. THEY DISCARDED THE INITIAL BLOCK AND PROCEEDED TO PREPARE A SECOND ONE. DURING THE PREPARATION OF A SEPARATE BLOCK FOR A DIFFERENT CASE, THEY OBSERVED THE SAME GRAY MATERIAL FLOATING IN THE SYRINGE, DESPITE USING A DIFFERENT BOTTLE OF 0.75% BUPIVACAINE THAT ALSO HAD A DIFFERENT LOT NUMBER. UPON FURTHER INVESTIGATION, THEY IDENTIFIED THAT THE GRAY MATERIAL WAS ORIGINATING FROM THE STOPPER OF THE BUPIVACAINE BOTTLE DURING THE ASPIRATION PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22382120 ↗
• MalfunctionMay 16, 2025Defective Component; Defective Component

  THE CUSTOMER REPORTED THAT OVER THE PAST FEW WEEKS SHE HAS NOTICED AN INCREASE OF CORING MEDICATIONS (PARTS OF THE RUBBER STOPPER IS GETTING SLICED BY BLUNT TIP NEEDLES AND BEING IN MEDICATION SYRINGES). THEY ARE SMALL PIECES BUT A RISK OF INJECTING THESE SMALL PIECES OF RUBBER INTO PATIENTS IS VERY POSSIBLE. SOME RUBBER PARTS ARE PREVENTING EASY WITHDRAWAL OF MEDICATIONS FROM VIALS - WHILE OTHER ARE JUST FLOATING AROUND IN THE SYRINGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035696 ↗
• MalfunctionMay 16, 2025Defective Component; Defective Component

  THE CUSTOMER REPORTED THAT THEY HAVE BEEN USING A SUBSTITUTE NEEDLE TO DRAW UP DRUGS IN ANESTHESIA WHILE THEIR PRIMARY BLUNT TIP SYRINGE IS ON BACKORDER. ONE OF THEIR CRNAS HAD TWO INSTANCES WHERE THE BLUNTFILL NEEDLE CORED THE VIAL TOP AND SUCKED THE PIECE OF PLASTIC CORE INTO THE SYRINGE.IF HE HADN'T CAUGHT THIS IT WOULD HAVE THEN BEEN INJECTED INTO A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035620 ↗
• MalfunctionMay 16, 2025Defective Component; Defective Component

  " THE CUSTOMER REPORTED THAT WHEN USING THE CARDINAL NEEDLE TO DRAW UP MEDICATION, CORING OCCURRED RESULTING IN STOPPER FRAGMENTS FROM MEDICATION VIAL TOP APPEARING IN SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035458 ↗
• MalfunctionSep 20, 2021Nonstandard Device; Nonstandard Device

  THE CUSTOMER REPORTED WHEN DRAWING UP MEDICATION WITH THE BLUNT FILL, A PIECE OF THE RUBBER STOPPER OF THE MEDICATION VIAL WAS NOTED AT THE TIP OF THE NEEDLE. THE DEVICE WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12496933 ↗
• MalfunctionJun 28, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THE CUSTOMER REPORTS: BLUNT FILL NEEDLE HAD A WHITE GLUE SUBSTANCE ON THE NEEDLE WHEN TAKEN OUT OF PACKAGE.

  Patient problems: No Patient Involvement

  MAUDE report 7647806 ↗