Monoject 8881512258Recalls & reported problems
Cardinal Health, Inc. · 12 mL Pharmacy Tray,Luer-Lock Tip · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10884521010970), received between Mar 28, 2016 and Sep 15, 2023 — classified as 20 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (8 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
Device problems
- Device Contaminated During Manufacture or Shipping8
- Device Contamination with Chemical or Other Material3
- Fluid/Blood Leak3
- Failure to Infuse2
- Break1
- Contamination /Decontamination Problem1
- Contamination of Device Ingredient or Reagent1
- Difficult to Advance1
Patient problems
- Insufficient Information10
- No Clinical Signs, Symptoms or Conditions6
- No Patient Involvement5
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT DURING PRODUCTION ACTIVITIES, THERE WAS ONE LEAKING/CRACKED SYRINGE IDENTIFIED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17759815 ↗MalfunctionSep 15, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT DURING PRODUCTION ACTIVITIES, THERE WAS ONE LEAKING SYRINGE IDENTIFIED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17759542 ↗MalfunctionJul 14, 2021Failure to Infuse; Failure to Infuse
CUSTOMER REPORTS: THE RIDGES OF THE PLUNGER DOES NOT SEAL.
Patient problems: Insufficient Information
MAUDE report 12170450 ↗MalfunctionJul 14, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
CUSTOMER REPORTS: WHEN FILLING THE SYRINGES, THERE ARE BLACK PARTICLES FOUND IN SOME OF THE SYRINGES AND WHITE PARTICLES IN OTHER SYRINGES FROM THE LOT. THE CUSTOMER SENT THE PRODUCT TO A 3RD PARTY LAB FOR ANALYSIS AND THE WHITE FIBERS WERE IDENTIFIED AS CELLULOSE WITH SILICONE AND OXYGEN-RICH SURFACE PARTICLES AND THE BLACK FIBER DEFECTS WERE IDENTIFIED AS TEXTILE COTTON FIBERS WITH SPECTRAL INDICATIONS OF SILICONE.
Patient problems: Insufficient Information
MAUDE report 12170317 ↗MalfunctionJul 14, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
CUSTOMER REPORTS: WHEN FILLING THE SYRINGES, THERE ARE BLACK PARTICLES FOUND IN SOME OF THE SYRINGES AND WHITE PARTICLES IN OTHER SYRINGES FROM THE LOT. THE CUSTOMER SENT THE PRODUCT TO A 3RD PARTY LAB FOR ANALYSIS AND THE WHITE FIBERS WERE IDENTIFIED AS CELLULOSE WITH SILICONE AND OXYGEN-RICH SURFACE PARTICLES AND THE BLACK FIBER DEFECTS WERE IDENTIFIED AS TEXTILE COTTON FIBERS WITH SPECTRAL INDICATIONS OF SILICONE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12170269 ↗MalfunctionJul 14, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
CUSTOMER REPORTS: WHEN FILLING THE SYRINGES, THERE ARE BLACK PARTICLES FOUND IN SOME OF THE SYRINGES AND WHITE PARTICLES IN OTHER SYRINGES FROM THE LOT. THE CUSTOMER SENT THE PRODUCT TO A 3RD PARTY LAB FOR ANALYSIS AND THE WHITE FIBERS WERE IDENTIFIED AS CELLULOSE WITH SILICONE AND OXYGEN-RICH SURFACE PARTICLES AND THE BLACK FIBER DEFECTS WERE IDENTIFIED AS TEXTILE COTTON FIBERS WITH SPECTRAL INDICATIONS OF SILICONE.
Patient problems: Insufficient Information
MAUDE report 12170237 ↗MalfunctionJul 14, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
CUSTOMER REPORTS: WHEN FILLING THE SYRINGES, THERE ARE BLACK PARTICLES FOUND IN SOME OF THE SYRINGES AND WHITE PARTICLES IN OTHER SYRINGES FROM THE LOT. THE CUSTOMER SENT THE PRODUCT TO A 3RD PARTY LAB FOR ANALYSIS AND THE WHITE FIBERS WERE IDENTIFIED AS CELLULOSE WITH SILICONE AND OXYGEN-RICH SURFACE PARTICLES AND THE BLACK FIBER DEFECTS WERE IDENTIFIED AS TEXTILE COTTON FIBERS WITH SPECTRAL INDICATIONS OF SILICONE.
Patient problems: Insufficient Information
MAUDE report 12170198 ↗MalfunctionJul 14, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
CUSTOMER REPORTS: WHEN FILLING THE SYRINGES, THERE ARE BLACK PARTICLES FOUND IN SOME OF THE SYRINGES AND WHITE PARTICLES IN OTHER SYRINGES FROM THE LOT. THE CUSTOMER SENT THE PRODUCT TO A 3RD PARTY LAB FOR ANALYSIS AND THE WHITE FIBERS WERE IDENTIFIED AS CELLULOSE WITH SILICONE AND OXYGEN-RICH SURFACE PARTICLES AND THE BLACK FIBER DEFECTS WERE IDENTIFIED AS TEXTILE COTTON FIBERS WITH SPECTRAL INDICATIONS OF SILICONE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12170143 ↗MalfunctionApr 27, 2021Break; Break
THE CUSTOMER REPORTED AN ISSUE WITH A MONOJECT 12ML SYRINGE STATING THAT A PATIENT HAD A DOUBLE LUMEN PICC PLACED AND RECEIVED TPA IN BOTH PORTS AT 2200 AND 2300. UPON REMOVAL OF THE MONOJECT SYRINGE, IT WAS NOTED THAT THE PLASTIC NIPPLE OF THE SYRINGE THAT INSERTS INTO THE PICC LINE WAS MISSING. UPON EXAMINING THE PORT, IT WAS NOTED THAT THE PLASTIC NIPPLE WAS IN THE PORT. THE BEDSIDE NURSE WAS AWARE AND THE PICC LINE WAS REMOVED. THE MEDICAL DOCTOR WAS NOTIFIED. NO FURTHER INFORMATION CAN BE OBTAINED AS THE INITIAL REPORTER WAS NOT IDENTIFIED.
Patient problems: Insufficient Information
MAUDE report 11731750 ↗MalfunctionApr 26, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
CUSTOMER REPORTS: ONE OF THE SYRINGES HAS FREE FLOATING PARTICLES.
Patient problems: Insufficient Information
MAUDE report 11728091 ↗MalfunctionApr 26, 2021Fitting Problem; Failure to Infuse; Fitting Problem; Failure to Infuse
THE CUSTOMER REPORTED THAT THE PISTONS ARE TOO LOOSE OR TOO TIGHT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11727840 ↗MalfunctionApr 26, 2021Difficult to Advance; Difficult to Advance
CUSTOMER REPORTS: THE PLUNGER ON SOME OF THE SYRINGES ARE STICKING.
Patient problems: Insufficient Information
MAUDE report 11727384 ↗MalfunctionFeb 9, 2021Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THEY HAVE MULTIPLE SYRINGES THAT ARE LEAKING BETWEEN THE BARREL AND THE PLUNGER. SOMETIMES THE LEAKING STARTS AS SOON AS THEY START TO FILL THEM. THEY ARE FILLED WITH A BAXTER REPEATER PUMP ON A MEDIUM SPEED USING TUBING AND A LUER LOCK ASSEMBLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11300463 ↗MalfunctionOct 13, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
THE CUSTOMER REPORTED THERE WAS AN INSECT IN THE SYRINGE BARREL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10673852 ↗MalfunctionJul 11, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
THE CUSTOMER REPORTED A SYRINGE WITH A FUZZY RED PARTICLE IN IT.
Patient problems: No Patient Involvement
MAUDE report 8781541 ↗MalfunctionJul 11, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
THE CUSTOMER REPORTED THAT THERE IS A FIBROUS STRAND AND A PARTICULATE MATTER FOUND IN A TRAY AND A FIBROUS STRAND FOUND IN THE NEEDLE PORT OF 1 SYRINGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8780130 ↗MalfunctionJul 8, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
THE CUSTOMER REPORTS FIBERS AND PARTICULATE MATTER FOUND IN 3 SYRINGES AND 4 TRAYS.
Patient problems: No Patient Involvement
MAUDE report 8768396 ↗MalfunctionMay 13, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
THE CUSTOMER STATES A FOREIGN MATTER WAS FOUND ON ONE SYRINGE UNDERNEATH THE HEAD AND ALONG THE UPPER HALF OF THE PLUNGER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8603827 ↗MalfunctionJun 7, 2017Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
THE CUSTOMER REPORTS PARTICULATE WAS DISCOVERED IN A 12 ML LL SYRINGE.
Patient problems: No Patient Involvement
MAUDE report 6619856 ↗MalfunctionMar 28, 2016Contamination of Device Ingredient or Reagent
A COVIDIEN MONOJECT 12 ML SYRINGE HAD SOME SORT OF BROWN CONTAMINANT ON PART OF THE PLUNGER WALL WHEN IT WAS REMOVED FROM THE PACKAGING. THE DEFECT WAS FOUND BEFORE IT WAS USED. IT CAME FROM A 12ML PHARMACY TRAY WITH LUER-LOCK TIP.
Patient problems: No Patient Involvement
MAUDE report 5537510 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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