Monoject 1181200777Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521010000), received between Oct 25, 2019 and Jul 8, 2021 — classified as 1 injury, 5 malfunctions.

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

• MalfunctionJul 8, 2021Contamination; Contamination

  THE CUSTOMER STATED THAT A BROWN SPOT WAS FOUND INSIDE THE SYRINGE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12139078 ↗
• MalfunctionMay 24, 2021Contamination; Contamination

  THE CUSTOMER REPORTED THEY HAVE FOUND CONTAMINATION IN AND ON THE SYRINGES. IT APPEARS TO BE BLACK OR GREEN MOLD LIKE AND IS FOUND IN THE STOCK ON A VARIETY OF FLOORS. ADDITIONAL INFORMATION RECEIVED STATED THE CONTAMINATION IS BOTH INSIDE AND OUTSIDE THE SYRINGE IN THE FLUID PATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11870132 ↗
• MalfunctionMay 19, 2021Contamination; Contamination

  THE CUSTOMER REPORTED THEY HAVE FOUND CONTAMINATION IN AND ON THE SYRINGES. IT APPEARS TO BE BLACK OR GREEN MOLD LIKE AND IS FOUND IN THE STOCK ON A VARIETY OF FLOORS. ADDITIONAL INFORMATION RECEIVED STATED THE CONTAMINATION IS BOTH INSIDE AND OUTSIDE THE SYRINGE IN THE FLUID PATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11848575 ↗
• MalfunctionJul 23, 2020Break; Break

  THE CUSTOMER REPORTED THAT THE SYRINGE FILLED WITH MEDICATION WAS CONNECTED INTO THE SIDE PORT OF THE PRIMARY TUBING TO ADMINISTER THE MEDICATION. THE LUER LOCK SNAPPED OFF AND BROKE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10317687 ↗
• MalfunctionMar 11, 2020Fitting Problem; Fitting Problem

  THE CUSTOMER REPORTED THAT THEY HAD DIFFICULTY ATTACHING THE 12ML SYRINGES TO THE BRAUN #490402 EXTENSION SET.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9818525 ↗
• InjuryOct 25, 2019Break; Break

  THE CUSTOMER REPORTED A BROKEN FLANGE. ADDITIONAL INFORMATION RECEIVED FROM THE CARDINAL HEALTH SALES REPRESENTATIVE STATED THAT WHEN THE PHYSICIAN WAS DOING AN EMERGENCY TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE, THE SYRINGE FLANGE BROKE DURING A HAND INJECTION FOR VENOGRAM. THE BROKEN EDGE OF THE SYRINGE TORE THROUGH PHYSICIAN 'S BLOODY GLOVE AND CUT THROUGH HIS SKIN. THE PATIENT WAS KNOWN (B)(6). THE PATIENT WAS (B)(6). HE HAS (B)(6) BY (B)(6) TESTING. CURRENTLY, THE STATUS OF (B)(6) IS UNKNOWN. THE PHYSICIAN BROKE THE SCRUB, CLEANED HIS WOUND AND CONTINUED TO COMPLETE THE CASE. AFTER THE PROCEDURE, THE PHYSICIAN WENT TO THE EMERGENCY DEPARTMENT FOR POST EXPOSURE TESTING. BLOOD WAS DRAWN. DTAP, (B)(6) (4 SHOTS) WERE RECEIVED. APPROXIMATELY 3 HOURS WERE SPENT IN THE EMERGENCY ROOM (ER). CDC/UCSF PHYSICIAN HOTLINE WAS CONTACTED FOR ASSISTANCE. THE PHYSICIAN IS CURRENTLY DOING WELL. THE PHYSICIAN HAS BEEN INSTRUCTED TO GET (B)(6) COUNT TESTING IN 6 WEEKS AND (B)(6) TESTING IN 24 WEEKS.

  Patient problems: Injury

  MAUDE report 9238455 ↗