Monoject 8881513207 (UDI 20192253030690)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20192253030690), received between Aug 3, 2022 and Oct 22, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED LEAKAGE OF LIQUID (MEDICATIONS) THROUGH THE PLUNGER OF THE SYRINGES. THE PROBLEM MAY OCCUR ON MORE THAN HALF OF THE SYRINGES IN THE SAME TRAY. ON SOME SYRINGES, THE PRODUCT LEAKS BETWEEN THE 2 THEORETICALLY SEALED SECTIONS OF THE PISTON. ON OTHER SYRINGES, THE DRUG FLOWS AND COMES OUT OF THE SYRINGE FROM THE PLUNGER. THE CUSTOMER FURTHER STATED THAT THE SYRINGES ARE NOT LEAK-PROOF AND DO NOT MAINTAIN THE STERILITY OF MEDICATIONS. RISK OF DRUG LOSS (INCOMPLETE DOSE) AND CONTAMINATION OF DOSES WITH MICROORGANISMS. IN ADDITION, THE SYRINGES ARE INTERPOSED INSIDE THE TRAY. THIS MEANS THAT PHARMACY DISPENSERS CANNOT PROTECT CRITICAL SYRINGE SITES EASILY (GO OVER THE SYRINGE TIPS IN THE ROW BELOW WHEN TRYING TO PICK UP SYRINGES FROM THE TOP ROW). THIS INCREASES THE RISK OF CONTAMINATING SUPPLIES DURING HANDING. THEY HAVE LOST MANY DOSES OF MEDICATION BECAUSE THE MEDICATION HAD LEAKED INTO THE PLUNGER OF THE SYRINGE (THE PRODUCT IS NO LONGER CONSIDERED STERILE). THE DOSES HAVE BEEN REDONE. TO SOLVE THIS ISSUE, THEY HAVE CHANGED THE PREPARATION OF SEVERAL DRUGS TO 5ML SYRINGES DESPITE A RISK THAT THE VOLUME WILL BE LESS ACCURATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20502203 ↗
• MalfunctionAug 3, 2022Break; Break

  THE CUSTOMER REPORTED THAT THAT DURING INSPECTION OF LOT 2206721564, THEY FOUND SEVERAL PLUNGERS WITH PARTICULATE, PARTICULATE AT THE TIP, AND BROKEN SYRINGES. A PHOTO PROVIDED SHOWS THE BREAKS THE CUSTOMER IS REFERRING TO ARE BROKEN LUER TIPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15159649 ↗
• MalfunctionAug 3, 2022Break; Crack; Break; Crack

  THE CUSTOMER REPORTED THAT DURING INSPECTION OF LOT 2209408764, SEVERAL SYRINGES WERE REJECTED FOR PARTICULATE MATTER ON THE PLUNGER AND BROKEN SYRINGES, LEADING TO THE LOT FAILING INSPECTION. A PHOTO PROVIDED SHOWS THE BREAKS THE CUSTOMER IS REFERRING TO ARE A BROKEN LUER TIP, A CRACKED BARREL, AND A BROKEN FINGER FLANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15159624 ↗