Monoject 8881540111Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 30884521102754), received between Sep 23, 2019 and Jul 3, 2024 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE TIP IS NOT THREADING DOWN INTO THE SYRINGE ALL THE WAY CAUSING IT TO LEAK MEDICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19669807 ↗
• MalfunctionFeb 15, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT WHEN THE RN OR MD IS DRAWING UP MEDICATIONS, THE MEDICATIONS IS VIOLENTLY SPEWING OUT OF THE VERY SMALL VENT HOLE ON THE SIDE OF IT. IT IS CAUSING EXTRA MEDICATION TO BE DRAWN UP FOR PATIENTS AND A MESS FOR OUR STAFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18712937 ↗
• MalfunctionJul 28, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE MICRO PIN AND A SYRINGE WERE INSERTED INTO A VIAL. THE USER FOUND IT DIFFICULT TO INSERT FLUID DUE TO HIGH PRESSURE. THE VIAL SHATTERED. VIAL SHATTERED. THE STAFF MEMBER NOTED THERE WAS A THIRD STREAM OF FLUID LEAKING FROM THE HUB OF THE MICRO PIN. STAFF MEMBER DISCARDED THE FAULTY PRODUCT. THEY WERE UNABLE TO REPLICATE THE ISSUE WITH OTHER STOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17416578 ↗
• MalfunctionJul 26, 2023

  CAP THAT COME WITH PLASTIC NEEDLE DOES NOT LATCH ON PROPERLY AND NOT SECURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17396476 ↗
• MalfunctionAug 24, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THEY HAVE EXPERIENCED ISSUES WITH THIS PRODUCT LEAKING OUT OF THE SIDE OF THE CANNULA WHEN PULLING MEDICATION OUT OF A VIAL AND SPRAYING OUT TOWARDS THE CLINICIAN. ADDITIONALLY, THE CAPS HAVE ALSO BEEN REPORTED TO FALL OFF VERY EASILY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12358812 ↗
• MalfunctionJul 30, 2021Fluid/Blood Leak; Connection Problem; Fluid/Blood Leak; Connection Problem

  THE CUSTOMER REPORTED THAT WHEN DRAWING UP THE DRUG FENTANYL, IN THEIR GI CENTER, THE MEDICATION SPRAYED OUT OF THE SIDES OF THE NEEDLELESS CANNULA AT THE CONNECTION WHERE IT WAS ATTACHED TO THE BD SYRINGE. THE CUSTOMER IS UNSURE IF THE ISSUE WAS WITH THE CANNULA OR THE SYRINGE. THE MEDICATION HAD TO BE WASTED. ANECDOTALLY, THIS HAS HAPPENED TO SEVERAL OTHER NURSES WHILE DRAWING UP THEIR DRUGS ALSO. THERE HAS BEEN NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12253016 ↗
• MalfunctionJul 15, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE MONOJECT NEEDLELESS MED PREP CANNULA SPRAYED A STREAM OF FLUID OUT OF THE SIDE, NOT JUST THE TIP. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12177957 ↗
• MalfunctionFeb 22, 2021Contamination; Contamination

  THE CUSTOMER REPORTED UPON OPENING THE CANNULA AND STARTING TO DRAW UP CONTRAST, THE CANNULA WAS SEEN TO HAVE A BROWN SUBSTANCE INSIDE THE CANNULA PRIOR TO DRAWING UP THE CONTRAST. THE X-RAY TECH ABORTED THE PROCESS AND RETRIEVED A NEW CANNULA WITH A DIFFERENT LOT NUMBER TO REPEAT THE PROCESS. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11358715 ↗
• MalfunctionJan 27, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE DRUG WAS SQUIRTING OUT OF A SMALL HOLE OR CRACK OF THE MONOJECT SMARTIP NEEDLELESS VIAL ACCESS CANNULA. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11236625 ↗
• MalfunctionDec 16, 2020Contamination; Contamination

  THE CUSTOMER REPORTED THAT THE PRIMARY REGISTERED NURSE (RN) ATTACHED NEEDLE TIP TO 30 CC SYRINGE. THE NURSE DREW UP 20CC STERILE WATER FROM ONE VIAL AND CEFEPIME FROM ANOTHER VIAL TO MIX. THE SOLUTION WAS APPROPRIATE YELLOW IN COLOR IN THE SYRINGE. WHEN PRIMARY RN REMOVED THE NEEDLE CAP, A DARK BROWN/BLACK MOLD LOOKING SUBSTANCE WAS NOTICED ON SYRINGE BASE. THE NURSE REDREW UP MEDICATION WITH ALL NEW MATERIALS. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11023420 ↗
• MalfunctionSep 18, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE CUSTOMER REPORTED THAT WHEN THE ITEM WAS OPENED FROM THE PACKAGE, THE RN NOTED THAT THERE WAS SOME SORT OF CONTAMINATION TO THE DEVICE. IT WAS DISCOLORED WITH SEDIMENT. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATED THAT THE CONTAMINATION WITH SEDIMENT WAS FOUND INSIDE THE SYRINGE BARREL. THE ISSUE WAS DISCOVERED BEFORE USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10553629 ↗
• MalfunctionFeb 17, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE CUSTOMER REPORTED THAT THE CANNULA APPEARED TO BE DIRTY INSIDE WHEN OPENED. THERE APPEARS TO BE A DRIED BLOOD ON CANNULA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9717044 ↗
• MalfunctionDec 20, 2019Break; Break

  THE CUSTOMER REPORTED THAT THE SMART TIP CANNULA IS BREAKING OFF AT THE BASE WHILE DRAWING UP MEDICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9506003 ↗
• MalfunctionDec 3, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE REGISTERED NURSE ATTACHED NEEDLELESS CANNULA TO SYRINGE, DREW UP AIR, INSERTED NEEDLELESS CANNULA INTO ZOFRAN VIAL, AND PUSHED IN AIR. THE MEDICATION SHOT OUT OF THE SIDE OF THE NEEDLELESS CANNULA AND THE DOSAGE WAS WASTED. THE REGISTERED NURSE TESTED ANOTHER NEEDLESS CANNULA FROM THE SAME LOT NUMBER AND LEAKING WAS NOTICED AGAIN. NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9402859 ↗
• MalfunctionNov 8, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE CUSTOMER REPORTED THAT THE CERTIFIED REGISTERED NURSE ANESTHETIST NOTED VISIBLE BLACK PARTICLES IN THE MONOJET NEEDLELESS BLUNT CANNULA. THIS WAS NOTED WHEN THE MEDICATION WAS DRAWN UP, WHICH WAS NOT GIVEN TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9298011 ↗
• MalfunctionNov 5, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE CUSTOMER REPORTED THAT WHEN THE ANESTHESIA RESIDENT ATTACHED A BLUNT NEEDLE TO A SYRINGE WITH PREFILLED SALINE FLUSH, THE RESIDENT NOTICED THAT THERE WAS WHAT APPEARED TO BE MOLD ON THE BLUNT NEEDLE. IT DID NOT REACH THE PATIENT AND THE BLUNT NEEDLE WAS CONFISCATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9281920 ↗
• MalfunctionOct 17, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THE CUSTOMER REPORTED THEY FOUND 3 BLUNT TIP CANNULAS WITH MOLD INSIDE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9202140 ↗
• MalfunctionOct 3, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE NEEDLE SHOOTS FLUID OUT AT THE SIDE OF THE NEEDLE WHEN UNDER PRESSURE AT 90 DEGREES NEAR THE NEEDLE'S BASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9151042 ↗
• MalfunctionSep 23, 2019Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED THAT THE PRODUCT WAS LEAKING WHEN TRYING TO DRAW UP MEDICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9104871 ↗