Monoject 8881560125Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 20884521012230), received between Jun 15, 2017 and Nov 15, 2024 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Break” (10 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Apr 23, 2024Completed

   Quarantined product was inadvertently distributed

   Z-2039-2024 · Root cause: Component change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2024Break; Break

  THE CUSTOMER REPORTED THAT THEY RECEIVED SYRINGES, HOWEVER, THE LUER LOCK TIP IS MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20694339 ↗
• MalfunctionJul 22, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE TIP BROKE OFF DURING INFUSION, AND LED TO MEDICATION LEAKING OUT AND NOT BEING ADMINISTERED TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED ON 22JUL2024 STATED THAT THE PATIENT RECEIVED A DOSE, BUT THE DOSE WAS DELAYED AS THIS ONE LEAKED WHEN ATTACHING TO THE PATIENT. THE MEDICATION HAD TO BE REMADE IN ANOTHER SYRINGE. THERE WAS NO HARM OR INJURY TO THE PATIENT DUE TO THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19795241 ↗
• MalfunctionJul 10, 2024Break; Break

  THE CUSTOMER REPORTED THAT THE LUER-LOCK TIP BROKE OFF AND REMAINED INSIDE THE TIP CAP WHEN THE RN (REGISTERED NURSE) WAS GOING TO ADMINISTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19710976 ↗
• MalfunctionJun 27, 2024Break; Break

  THE CUSTOMER REPORTED THAT THE LUER-LOCK TIP BROKE OFF AND REMAINED INSIDE THE TIP CAP WHEN THE RN (REGISTERED NURSE) WAS GOING TO ADMINISTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19629830 ↗
• MalfunctionJul 18, 2023Break; Break

  THE CUSTOMER REPORTED THAT WHEN USING THESE SYRINGES IN THE HAZARDOUS COMPOUNDING HOOD, THE TIP THAT WOULD GO INTO THE HUB OF THE NEEDLE IS BREAKING OFF. THEY ARE UNABLE TO SPECIFICALLY LOCATE WHEN THE ISSUE HAPPENED. THEY TRIED TO REENACT THE ISSUE IN THE PHARMACY, AND IT ACTUALLY BROKE WITH JUST PUTTING THE CHEMO LOCK ADAPTER ON THE SYRINGE. PER ADDITIONAL INFORMATION RECEIVED, THERE WAS NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17342056 ↗
• MalfunctionJul 18, 2023Break; Break

  THE CUSTOMER REPORTED THAT WHEN USING THESE SYRINGES IN THE HAZARDOUS COMPOUNDING HOOD, THE TIP THAT WOULD GO INTO THE HUB OF THE NEEDLE IS BREAKING OFF. THEY WERE UNABLE TO SPECIFICALLY LOCATE WHEN THE ISSUE HAPPENED. THEY DO KNOW THAT THERE WAS ONE THAT WAS IN THE IV HOOD ROOM THAT BROKE WITH NOTHING IN THE SYRINGE. PER ADDITIONAL INFORMATION RECEIVED, THERE WAS NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17342055 ↗
• MalfunctionJul 18, 2023Break; Break

  THE CUSTOMER REPORTED THAT WHEN USING THESE SYRINGES IN THE HAZARDOUS COMPOUNDING HOOD, THE TIP THAT WOULD GO INTO THE HUB OF THE NEEDLE IS BREAKING OFF. ONE MOST RECENTLY BROKE ON (B)(6) 2023. THIS HAD A DRUG CALLED GEMCITABINE IN THE SYRINGE. THEY TAPPED THE SIDE OF THE SYRINGE TO GET AIR BUBBLES TO MOVE AND THE SYRINGE TIP BROKE AND THE VIAL WAS STILL ATTACHED WITH THE SYRINGE ADAPTER AND VIAL ADAPTERS. THERE WAS NO DRUG SPILLAGE. PER ADDITIONAL INFORMATION RECEIVED, THERE WAS NO MEDICAL INTERVENTION REQUIRED. THERE WAS NO SPILL, DAMAGE, OR HARM DONE TO STAFF OR PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17342050 ↗
• MalfunctionJul 18, 2023Break; Break

  THE CUSTOMER REPORTED THAT WHEN USING THESE SYRINGES IN THE HAZARDOUS COMPOUNDING HOOD, THE TIP THAT WOULD GO INTO THE HUB OF THE NEEDLE IS BREAKING OFF. WHEN THE ISSUE OCCURRED, THEY WERE MAKING CHEMOTHERAPY AND USING THE CHEMO LOCK ITEMS THAT MAKE THE COMPOUNDING A CLOSED SYSTEM. PER ADDITIONAL INFORMATION RECEIVED, THERE WAS NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17342042 ↗
• MalfunctionMar 28, 2023Break; Break

  THE CUSTOMER REPORTED THAT THEY ORDERED 25 CASES AND RECEIVED IT ON MARCH 14, 2023. UPON INSPECTION, THEY NOTICED THAT 7 PCS OF HAVE BROKEN TIPS AND CANNOT BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16628803 ↗
• MalfunctionSep 23, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  THE CUSTOMER REPORTED THAT A 60ML MONOJECT SYRINGE WAS USED IN A B BRAUN PUMP FOR LIPIDS AND IT FAILED TO INJECT. THEY CHANGED THE PUMP AND TUBING, BUT THE SYRINGE STILL WOULDN'T INJECT PROPERLY. PER ADDITIONAL INFORMATION RECEIVED ON SEPTEMBER 8, 2022, THE PLUNGER WAS STICKING. THEY HAD TO GET ANOTHER SET OF LIPIDS FROM THE PHARMACY TO USE IN A DIFFERENT SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15473809 ↗
• MalfunctionMar 16, 2020Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT DURING PREPARING THE CHEMOTHERAPY FOR HOSPITAL INPATIENT, WHILE PREPARING DOXORUBICIN SYRINGE FOR INTRAVENOUS (IV) ADMINISTRATION, THE LUER LOCK PORTION OF THE SYRINGE BROKE, WHEN TAPPING THE SYRINGE TO ELIMINATE BUBBLES FROM THE SOLUTION. SEVERAL DROPS FELL AND WERE ABSORBED BY THE CHEMO PAD. THE DRUG WAS TRANSFERRED FROM THE BROKEN SYRINGE TO A NEW SYRINGE USING A NEEDLE, WHICH SLOWED THE PREPARATION AND WASTED A SMALL AMOUNT OF DRUG.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9837109 ↗
• MalfunctionNov 13, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THE CUSTOMER REPORTED TO THE DISTRIBUTOR THAT THERE WAS PLASTIC INSIDE THE SYRINGE AND WHEN FLUID WAS DRAWN UP IT APPEARED FLOATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9316427 ↗
• MalfunctionAug 14, 2019Fluid/Blood Leak; Incomplete or Inadequate Connection; Fluid/Blood Leak; Incomplete or Inadequate Connection

  THE CUSTOMER REPORTED THAT THEY EXPERIENCED LEAKING ISSUES WHEN ADMINISTERING MONOJECT LUER LOCK SYRINGE TO AN ICU MEDICAL IV CONNECTOR. THE SYRINGE IS NOT CONNECTING FULLY TO THE IV CONNECTOR AND WHEN PRESSURE APPLIED ON THE SYRINGE TO ADMINISTER THE DRUG, IT LEAKS AT THE CONNECTOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8894563 ↗
• MalfunctionAug 14, 2019Fluid/Blood Leak; Incomplete or Inadequate Connection; Fluid/Blood Leak; Incomplete or Inadequate Connection

  THE CUSTOMER REPORTED THEY HAD EXPERIENCED LEAKING ISSUES WHEN ADMINISTERING FROM A MONOJECT LUER LOCK SYRINGE TO A ICU MEDICAL IV CONNECTOR. ESSENTIALLY, THE SYRINGE IS NOT CONNECTING FULLY TO THE IV CONNECTOR. THEN WHEN PRESSURE IS APPLIED ON THE SYRINGE TO ADMINISTER THE DRUG, IT LEAKS AT THE CONNECTOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8893644 ↗
• MalfunctionAug 8, 2017Particulates; Particulates

  THE CUSTOMER REPORTS BROWN RESIDUE IN THE SYRINGE. THE RESIDUE WAS FREE FLOATING AND WOULD CONTACT THE FLUID PATH OF THE SYRINGE. IT ALMOST LOOKED LIKE A DRIED INSECT OR SOME DRIED RESIDUE IN THE TOP OF THE SYRINGE INTERIOR NEAR THE CONNECTION FOR THE NEEDLE.

  Patient problems: No Patient Involvement

  MAUDE report 6774675 ↗
• MalfunctionAug 8, 2017Leak/Splash; Leak/Splash

  THE CUSTOMER STATES THAT THE SYRINGE WAS LEAKING FROM THE PLUNGER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6774284 ↗
• MalfunctionJun 15, 2017Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THE CUSTOMER STATES THAT THERE APPEARS TO BE A SHAVING ON THE PLUNGER. LOOKS LIKE CARDBOARD OR SOME OTHER MATERIAL.

  Patient problems: No Patient Involvement

  MAUDE report 6644571 ↗