Monoject 8881513934 (UDI 20884521012858)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 20884521012858), received between Jul 26, 2019 and Mar 12, 2024 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2024Break; Break

  THE CUSTOMER REPORTED THAT THE SYRINGES HAD THE LUER TIP OF THE SYRINGE BROKEN BEFORE THEY WERE OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18889065 ↗
• MalfunctionMar 12, 2024Break; Break

  THE CUSTOMER REPORTED THAT THE SYRINGES HAD THE LUER TIP OF THE SYRINGE BROKEN BEFORE THEY WERE OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18889062 ↗
• MalfunctionApr 25, 2023Break; Air/Gas in Device; Break; Air/Gas in Device

  THE CUSTOMER REPORTED THAT WHEN DRAWING THE VACCINATION UP, THEY ARE NOTICING THERE IS A CONSTANT INTRODUCTION OF AIR INTO THE SYRINGE FROM THE RUBBER STOPPER. IT SORT OF LOOKS LIKE THE LIQUID IS SIMMERING. THEY WERE TRYING TO DIAGNOSE WHAT WAS GOING ON EXACTLY, AND THE MIDDLE TIP PART OF THE SYRINGE SNAPPED. WHEN THEY SEE THE "SIMMERING", THEY PUSH THE VACCINATION BACK INTO THE VIAL, THROW THAT SYRINGE AWAY AND GRAB ANOTHER ONE FROM THE BOX. AGAIN, THAT IS ABOUT 15%-25% OF THE SYRINGES THAT THEY ARE TOSSING. PER ADDITIONAL INFORMATION RECEIVED, THE SYRINGE SNAPPED AT THE LUER LOCK AREA. THEY TOSSED THE SYRINGES AND USED NEW ONES WITHOUT THE DEFECT FOR VACCINATIONS. MEDICAL INTERVENTION WAS NOT REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16807351 ↗
• InjuryJun 4, 2021Material Deformation; Material Deformation

  CUSTOMER REPORTS: QC HAS SAMPLED 80 SYRINGES AND FOUND ONE WITH DEFORMED / SLIGHTLY BROKEN END AND TWO WITH SMALL THREADS OF PLASTIC.

  Patient problems: Insufficient Information

  MAUDE report 11942805 ↗
• MalfunctionJun 4, 2021Material Deformation; Material Deformation

  CUSTOMER REPORTS: QC HAS SAMPLED 80 SYRINGES AND FOUND ONE WITH DEFORMED / SLIGHTLY BROKEN END AND TWO WITH SMALL THREADS OF PLASTIC.

  Patient problems: Insufficient Information

  MAUDE report 11942633 ↗
• MalfunctionApr 19, 2021Contamination; Contamination

  THE CUSTOMER REPORTED THAT THEY RECEIVED A DELIVERY OF 3 ML SYRINGES, ITEM CODE 8881513934, THAT HAD PLASTIC THREADS IN THEM WHICH WAS NOT NOTICED UNTIL THEY MANUFACTURED A BATCH WITH THEM. PER THEIR QC, THEY WILL REJECT THE DELIVERY FROM LOT NUMBER 933618 WHICH WAS RECEIVED ON OCTOBER 09, 2020 DUE TO THE PRESENCE OF PLASTIC THREADS INSIDE OF THE SYRINGES WHICH ARE NOT DETECTABLE UNTIL THE SYRINGE IS FILLED. THEY ONLY FOUND THE ISSUE WHEN THE FIRST BATCH OF BIOMED PRODUCT WAS FILLED AND 27% OF THE SYRINGES WERE OBSERVED WITH THE PLASTIC "THREADS" IN THEM. THEY ALSO SAW SIMILAR THREADS ON THE OUTSIDE OF THE SYRINGE BARRELS. THEY SHOW THAT THE THREADS INSIDE WERE THE SAME MATERIAL AS THE SYRINGE BARRELS BY FTIR ANALYSIS IN THE LABORATORY. THEY ARE REJECTING THE BATCH THAT WAS MADE AS THERE IS POTENTIALLY VERY SMALL PLASTIC SHAVINGS IN THE SYRINGES WHICH CANNOT BE DETECTED IN THE SIGHTING PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11685770 ↗
• MalfunctionApr 14, 2021Separation Problem; Separation Problem

  CUSTOMER REPORTS: THE LUER LOCK TIPS ON TWO DIFFERENT 3ML SYRINGES WERE FOUND BROKEN IN THEIR CONTAINERS. THIS WAS FOUND BY NURSE PRIOR TO USE ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11664563 ↗
• MalfunctionAug 28, 2020Break; Break

  THE CUSTOMER REPORTED THAT THE STAFF NOTICED A BROKEN SYRINGE BEFORE USING. UPON REVIEW OF THE PROVIDED PHOTOGRAPH, THE LUER TIP IS BROKEN.

  Patient problems: No Patient Involvement

  MAUDE report 10465105 ↗
• MalfunctionDec 2, 2019Improper Flow or Infusion; Improper Flow or Infusion

  THE CUSTOMER REPORTED THAT THE PLUNGER NOT SEALING INTO THE SYRINGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9397706 ↗
• MalfunctionNov 1, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT WHEN THE MEDICATION IS DRAWN UP INTO THE SYRINGE IN THE AIRFLOW HOOD IN THE PHARMACY, THE SYRINGE TIP BEGINS LEAKING AFTER THE CAP IS PUT ON. THE METHOD THAT IS USED TO CAP IS PRESSURE AGAINST THE HOODS COUNTER. THE SYRINGES ARE ALL FILLED TO 2 1/2 ML BEFORE CAPPING. THE LEAK OCCURRED AT THE PLUNGER END OF THE SYRINGE. THERE WERE NO PATIENTS INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 9265733 ↗
• MalfunctionJul 26, 2019Nonstandard Device; Nonstandard Device

  THE CUSTOMER REPORTED THAT THE SYRINGE WAS MISSING THE BLACK GRADUATION MARKINGS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8830485 ↗