Monoject 8881135609 (REF 8881135609-)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 20192253030652), received between Nov 30, 2022 and Mar 25, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED, BD MONOJECT SYRINGE HAD FOREIGN MATTER, OILY SUBSTANCE INSIDE. ADDITIONAL INFORMATION. SUBSTANCE, ONCE IT WAS DISCOVERED WE DID NOT MAKE THE NORMAL NARCOTIC PCA¿S THAT WE NORMALLY WOULD HAVE, THE SYRINGES WERE SEQUESTERED AND NO PRODUCT WENT TO PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24688532 ↗
• MalfunctionSep 19, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23099137 ↗
• MalfunctionSep 19, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  MATERIAL INSPECTION FOUND MULTIPLE SYRINGE LOTS WITH FIBERS AND PARTICLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23098432 ↗
• MalfunctionSep 4, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT BD PCA SET HAD FOREIGN MATTER THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT MULTIPLE BAGS WITHIN EACH CASE HAD A GREASY/OILY RESIDUE ON THE INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22974499 ↗
• MalfunctionSep 4, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT BD PCA SET HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT MULTIPLE BAGS WITHIN EACH CASE HAD A GREASY/OILY RESIDUE ON THE INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22974498 ↗
• MalfunctionNov 30, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT CARDBOARD-LIKE PARTICLES WERE FOUND ON THE STOPPER OF THE BD ALARIS¿ PCA MODULE SET EMPTY MONOJECT¿ SYRINGE BARREL IV SET ASSEMBLY IN THE SOLUTION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 6 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BROWN, CARDBOARD-LIKE PARTICLE ON SEPTUM ON SYRINGE, IN SOLUTION".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15884306 ↗
• MalfunctionNov 30, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BLUE PARTICLES WERE FOUND IN ONE BD ALARIS¿ PCA MODULE SET EMPTY MONOJECT¿ SYRINGE BARREL IV SET ASSEMBLY, FIBER WAS FOUND IN THE SOLUTION OF ANOTHER SYRINGE, AND PARTICLES WERE FOUND IN THE BARREL OF ANOTHER SYRINGE WITH GREASY SUBSTANCE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 6 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BLUE PARTICLE IN PLASTIC OF CONTAINER, INSIDE" "FIBER IN SOLUTION, INSIDE BARREL OF SYRINGE" "PARTICLES IN BARREL OF SYRINGE, BETWEEN SEPTUM AND BARREL, WITH GREASY SUBSTANCE PRESENT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15884303 ↗
• MalfunctionNov 30, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BLUE PARTICLES WERE FOUND IN ONE BD ALARIS¿ PCA MODULE SET EMPTY MONOJECT¿ SYRINGE BARREL IV SET ASSEMBLY, FIBER WAS FOUND IN THE SOLUTION OF ANOTHER SYRINGE, AND PARTICLES WERE FOUND IN THE BARREL OF ANOTHER SYRINGE WITH GREASY SUBSTANCE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 6 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BLUE PARTICLE IN PLASTIC OF CONTAINER, INSIDE". "FIBER IN SOLUTION, INSIDE BARREL OF SYRINGE", "PARTICLES IN BARREL OF SYRINGE, BETWEEN SEPTUM AND BARREL, WITH GREASY SUBSTANCE PRESENT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15884231 ↗
• MalfunctionNov 30, 2022Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE BD ALARIS¿ PCA MODULE SET EMPTY MONOJECT¿ SYRINGE BARREL IV SET ASSEMBLY STOPPER WAS MISALIGNED. THIS COMPLAINT WAS CREATED TO CAPTURE THE 4TH OF 6 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MISALIGNED SEPTUM; POTENTIAL CONTAINER/CLOSURE INTEGRITY ISSUE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15884230 ↗