Monoject 8881135609 (UDI 10884521155749)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10884521155749), received between Jan 6, 2022 and Dec 9, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2024Break; Break

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20880395 ↗
• MalfunctionDec 9, 2024Break; Break

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20880260 ↗
• MalfunctionMay 27, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD MON SYRINGE BARREL ASSEMBLY HAD FOREIGN MATTER WITHIN FLUID PATHWAY THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED I AM (B)(6), QA SUPERVISOR WITH STAQ PHARMA. WE RECENTLY DISCOVERED A TREND IN HIGH DEFECT RATES IN THREE OF OUR BATCHES WITH REGARDS TO PARTICLES/FIBERS FOUND ADHERED TO THE STOPPER ON BD MONOJECT SYRINGES, LOT # 2220719464. HAVE YOU HAD ANY COMPLAINTS OR ISSUES WITH THIS LOT NUMBER OF SYRINGES?

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19402443 ↗
• MalfunctionMay 27, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19402441 ↗
• MalfunctionNov 11, 2023Contamination; Contamination

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18117139 ↗
• MalfunctionNov 6, 2023Leak/Splash; Defective Component; Leak/Splash; Defective Component

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18080777 ↗
• MalfunctionNov 4, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD MON SYRINGE BARREL ASSEMBLY HAD FOREIGN MATTER.THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM:THEY DISCOVERED A MONOJECT SYRINGE WITH A BROWN PARTICLE STUCK IN THE SYRINGE WALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18070219 ↗
• MalfunctionSep 8, 2023Contamination; Contamination

  NO ADDITIONAL INFORMATION WAS PROVIDED. MAT#:8881135609. LOT#: 2213015864. IT WAS REPORTED BY CUSTOMER THAT MONOJECT SYRINGE WITH A BROWN PARTICLE FOUND INSIDE THE SYRINGE WALL. VERBATIM: RCC RECEIVED THE COMPLAINT VIA EMAIL. EMAIL AS ATTACHED. A MONOJECT SYRINGE WITH A BROWN PARTICLE FOUND INSIDE THE SYRINGE WALL. PLEASE SEE PRODUCT INFO BELOW: REF 8881135609. LOT# 2213015864. QUANTITY: (B)(4) SYRINGE. WED (B)(6) 2023 9:16 AM. HELLO, PLEASE SEE BELOW FOR REQUESTED INFO: 1. NO ADVERSE EVENTS, SO NONE REPORTED DUE TO INCIDENT. 2. SEE BELOW FOR PHOTOS. 3. DATE OF EVENT: 08/15/2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17711076 ↗
• MalfunctionApr 11, 2023Contamination; Contamination

  IT WAS REPORTED WHILE USING BD ALARIS¿ PCA MODULE SET EMPTY MONOJECT¿ SYRINGE BARREL IV SET ASSEMBLY FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED ISSUE PER CUSTOMER: EXCESS UNKNOWN SOLUTION WAS OBSERVED AROUND THE RIBCAGE AND ABOVE THE RUBBER STOPPER OF THE SYRINGE BARREL. CUSTOMER HAS 5 FULL CASES AND 1 PARTIAL CASE THAT HAS 11 PACKS OF 10 EACH WHICH EQUALS THE 860 EACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16718740 ↗
• MalfunctionNov 30, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD ALARIS¿ PCA MODULE SET EMPTY MONOJECT¿ SYRINGE BARREL IV SET ASSEMBLY EXPERIENCED FOREIGN MATTER WITHIN THE FLUID PATH. THIS COMPLAINT WAS CREATED TO CAPTURE THE 5TH OF 6 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FIBER IN SOLUTION, INSIDE BARREL OF SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15884239 ↗
• 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 15884237 ↗
• MalfunctionApr 15, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 7 BD 35ML MONOJECT¿ SYRINGE BARRELS EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PARTICULATES AND FIBERS DETECTED ON THE SYRINGE PLUNGER DURING QC INCOMING INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14120558 ↗
• MalfunctionJan 6, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER WAS DISCOVERED ON BD 35ML MONOJECT¿ SYRINGE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED SYRINGES WITH PARTICULATES ON THE PLUNGER / FM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13178256 ↗