Monoject 1180300777 (UDI 10884521012301)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10884521012301), received between Jul 11, 2019 and Nov 18, 2024 — classified as 2 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Crack” (11 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THEY HAD A TASS (TOXIC ANTERIOR SEGMENT SYNDROME) CASE RECENTLY. ADDITIONAL INFORMATION RECEIVED ON 06NOV2024 STATED THAT THE PATIENT WAS TREATED WITH INCREASED GTTS (DROPS) AND DIAMOX BID X 3D. THE PATIENT DID NOT HAVE ANY LONGSTANDING VISUAL DEFICIT. ON (B)(6) 2024, THE CUSTOMER CONFIRMED THERE WAS NO ISSUE WITH THE SYRINGE. THEY REPORTED THE EVENT DUE TO THE SYRINGE BEING USED DURING THE PROCEDURE.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 20708108 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THEY HAD A TASS (TOXIC ANTERIOR SEGMENT SYNDROME) CASE RECENTLY. ADDITIONAL INFORMATION RECEIVED ON 06NOV2024 STATED THAT THE PATIENT RESPONDED QUICKLY TO STEROIDS. NO INFLAMMATION BY DAY 6-7. NO LONG TERM COMPLICATIONS EXPECTED. ON (B)(6) 2024 THE CUSTOMER CONFIRMED THERE WAS NO ISSUE WITH THE SYRINGE. THEY REPORTED THE EVENT DUE TO THE SYRINGE BEING USED DURING THE PROCEDURE.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 20698482 ↗
• MalfunctionNov 13, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED SEVERAL ISSUES. THE FIRST ISSUE IS THAT THE GRADUATION MARKS ON THE SYRINGES ARE COMING OFF WAY TOO EASILY AND WORKING IN THE ANESTHESIA DEPARTMENT THIS ACTUALLY BECOMES A SAFETY RISK TO THE PATIENTS IF THE GRADUATIONS ARE COMING OFF AND THE DOCTORS ARE GIVING MORE MEDICATION THEN NEEDED ESPECIALLY WORKING WITH KIDS. SECOND ISSUE IS THAT THE PLUNGERS ARE SUPER FLIMSY. AND THERE IS NO SUCTION IN THE SYRINGES. ONCE AGAIN THIS GOES BACK TO PATIENT SAFETY. IF THE DOCTORS CANNOT CONTROL THE RATE AT WHICH THEY ARE PUSHING THE SYRINGES THEY WILL GIVE THE PATIENTS MORE MEDICATION THAN NEEDED. THIRD ISSUE IS THAT MEDICATION IS ACTUALLY LEAKING BECAUSE THE SYRINGE IS SO LOOSE. THEY WORK WITH PENTENYL AND OTHER DANGEROUS DRUGS SO ALSO A PATIENT SAFETY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18126073 ↗
• MalfunctionOct 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT SOME OF THE CRNAS ARE HAVING PROBLEMS WITH SYRINGES (MONOJECT) THAT HAVE BEEN DELIVERED TO THE SUPPLY ROOM. MEDICATION SQUIRTING OUT OF THEM, THE SYRINGE AND PLUNGER NOT LOCKING CORRECTLY, ETC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17892492 ↗
• MalfunctionApr 28, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  CUSTOMER REPORTS: THE SYRINGES WERE CRACKED AND THE ONES THAT WERE NOT, DID CRACK WHEN FLUID WAS INSERTED. THE INCIDENTS OCCURRED FROM JANUARY TO PRESENT WITH APPROXIMATELY 300 MALES AND FEMALES BETWEEN THE AGES OF 30-90. THERE WAS NO MEDICAL TREATMENT NECESSARY. ADDITIONAL INFORMATION RECEIVED ON 04/25/23 STATED THAT THE ISSUES OCCURRED DURING PAIN MANAGEMENT PROCEDURES TO CERVICAL AND LUMBAR AREAS. THE CRACKED SYRINGES DID LEAK DURING USE ON A PATIENT. THERE WAS NO PATIENT EFFECTED AS THE PHYSICIAN PREVENTED ANY HARM TO THE PATIENT/S.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16834456 ↗
• MalfunctionAug 23, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE CUSTOMER REPORTED WHEN THE NURSE IN ED WAS USING THIS PRODUCT, IT LEAKED OUT DILAUDID FROM A SPLIT ON THE SIDE WHILE AIR WAS BEING EXPELLED FROM THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15274802 ↗
• MalfunctionMay 25, 2021Crack; Crack

  THE CUSTOMER REPORTED THAT THE DEVICES ARE CRACKED. NO PATIENT INJURIES OR ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11877627 ↗
• MalfunctionSep 14, 2020Crack; Crack

  CUSTOMER REPORTS: THERE ARE HAIRLINE CRACKS IN THE SYRINGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10532308 ↗
• MalfunctionSep 14, 2020Crack; Crack

  CUSTOMER REPORTS: THERE ARE HAIRLINE CRACKS IN THE SYRINGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10532222 ↗
• MalfunctionSep 14, 2020Crack; Crack

  CUSTOMER REPORTS: THERE ARE HAIRLINE CRACKS IN THE SYRINGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10532187 ↗
• MalfunctionJul 14, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE CUSTOMER REPORTED THAT THE SYRINGE IS STICKING AND WILL NOT PUSH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10274072 ↗
• MalfunctionMar 11, 2020Fitting Problem; Fitting Problem

  THE CUSTOMER REPORTED THAT THEY HAD DIFFICULTY ATTACHING THE 3ML SYRINGE TO THE BRAUN #490402 EXTENSION SET.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9820794 ↗
• MalfunctionMar 10, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT AFTER THE NURSE DREW UP 2ML OF FENTANYL FROM A VIAL INTO THE SYRINGE AT THE NURSE STATION, SHE REAPPLIED THE CAP. WHEN SHE ARRIVED AT THE BEDSIDE, HER HAND FELT WET AND SHE OBSERVED THAT THE SYRINGE APPEARED TO HOLD ABOUT 25% LESS MEDICATION THAN IT DID ORIGINALLY. THERE WAS NO HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9810697 ↗
• MalfunctionFeb 28, 2020Nonstandard Device; Nonstandard Device

  THE CUSTOMER REPORTED THAT 31 SYRINGES WERE RECEIVED WITH NO TEXT OR PRINT ON THEM.

  Patient problems: No Patient Involvement

  MAUDE report 9769240 ↗
• MalfunctionDec 13, 2019Fluid/Blood Leak; Fitting Problem; Fluid/Blood Leak; Fitting Problem

  AS PER THE CUSTOMER, THE SYRINGE WILL NOT STAY CONNECTED TO THE ADMINISTRATION PORT ON THE TUBING. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATED THAT THE PLUNGER SEEMS TO BE TOO SMALL FOR THE SYRINGE AND NO SUCTION WITH 3 ML SYRINGE WHEN CONNECTED TO IV LINES AND LEAKING WAS NOTICED OUT OF THE SYRINGE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9468764 ↗
• MalfunctionDec 13, 2019Fluid/Blood Leak; Fitting Problem; Fluid/Blood Leak; Fitting Problem

  AS PER THE CUSTOMER, THE LUER LOCK OF THE 3 ML SYRINGE WAS NOT CONNECTING TIGHTLY TO THE MONOJECT BLUNTFILL 18 G X 1 ½¿ NEEDLE AND CAUSING THE NEEDLE TO DISCONNECT VERY EASILY FROM THE SYRINGE. ALSO, THE PLUNGER SEEMS TO BE TOO SMALL FOR THE SYRINGE AND THERE WAS NO OR LITTLE SUCTION WHEN DRAWING UP MEDICATION. AFTER DRAWING FROM A VIAL, THE MEDICATION WAS LEAKING OUT OF THE SYRINGE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9468431 ↗
• MalfunctionNov 12, 2019Material Fragmentation; Missing Information; Material Fragmentation; Missing Information

  THE CUSTOMER REPORTED THAT THE ANNOTATION ON THE SYRINGES WAS PEELING OFF AND CAN NO LONGER BE USED ON THE STERILE FIELD. ADDITIONAL INFORMATION RECEIVED ON 12-NOV-2019 STATED THAT BOTH THE TEXT AND THE GRADUATION MARKS WERE PEELING OFF THE SYRINGE AND TRANSFERRED TO THE ENTIRE FIELD AND ALSO THE SALINE BOWL AND INTO THE SYRINGES THEMSELVES. THERE WERE MISSING GRADUATION MARKS. IT WAS DISCOVERED ABOUT 1.5 HOURS INTO THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9312477 ↗
• MalfunctionAug 22, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE SYRINGES HAVE CRACKS AND ARE LEAKING. THIS WAS NOTICED BEFORE USE ON A PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8921563 ↗
• MalfunctionAug 22, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE SYRINGES HAVE CRACKS AND ARE LEAKING. THIS WAS NOTICED BEFORE USE ON A PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8921482 ↗
• MalfunctionAug 15, 2019Crack; Crack

  THE CUSTOMER STATED SEVERAL 3CC SYRINGES WERE DISCOVERED TO BE CRACKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8899546 ↗
• MalfunctionJul 31, 2019Nonstandard Device; Nonstandard Device

  THE CUSTOMER REPORTED THAT THE SYRINGE WAS LOSING SUCTION AND LEAKING AIR INTO THE TUBE. THEY HAD TO REDRAW THE SAMPLE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8846116 ↗
• MalfunctionJul 12, 2019Crack; Crack

  THE CUSTOMER REPORTED THAT THE SYRINGES WERE FOUND TO BE CRACKED INSIDE OF THE INDIVIDUAL PACKAGE. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8785361 ↗
• MalfunctionJul 11, 2019Crack; Crack

  THE CUSTOMER REPORTED THAT THEY FOUND CRACKED SYRINGES IN INVENTORY. THIS WAS DISCOVERED BEFORE USE.

  Patient problems: No Patient Involvement

  MAUDE report 8780453 ↗