Monoject 8881501160 (UDI 20884521013954)Recalls & reported problems
Cardinal Health, Inc. · 1 mL Tuberculin Syringe Detachable Needle · Class 2
All models of Monoject (164)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Cardinal Health Monoject tuberculin syringe uses a detachable needle. Reports mostly describe plungers that stick, bend or fail to create suction and let air in, with some needles coming loose in the cap. There are 26 reports that mention this identifier, with no deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 20884521013954), received between Jun 30, 2017 and Oct 24, 2023 — classified as 26 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Physical Resistance/Sticking7
- Air/Gas in Device4
- Crack4
- Detachment of Device or Device Component4
- Nonstandard Device3
- Mechanical Jam2
- Mechanical Problem2
- Component Incompatible1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- No Consequences Or Impact To Patient9
- No Patient Involvement6
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 24, 2023Physical Resistance/Sticking; Physical Resistance/Sticking
THE CUSTOMER REPORTED THAT THEY HAVE USED SEVERAL SYRINGES BUT THEY ARE NOT ALLOWING THEM TO PULL BACK ON THE SYRINGE FOR BLOOD COLLECTION. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER ON (B)(6) 2023 STATED THAT WHEN THEY WERE PULLING BLOOD, IT DID NOT HAVE A NEGATIVE PRESSURE TO IT. ON (B)(6) 2023 THE CUSTOMER CLARIFIED THAT THE PLUNGER WAS ABLE TO MOVE BUT THE RUBBER TIP WASN¿T SEALED TO THE BARREL CAUSING THE NO NEGATIVE PRESSURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17995654 ↗MalfunctionOct 11, 2022Air/Gas in Device; Air/Gas in Device
PER CUSTOMER REPORT: THE CLINIC'S TECHNICIAN SAY WHEN THEY ARE DRAWING UP THE BLOOD WITH THESE SYRINGES THEY TEND TO GET AIR AND THEN WHEN PULLING BACK THE PLUNGER IT IS EXTREMELY FLIMSY AND BENDS. THE SEAL SEEMS TO BE FINE WITH THEM THOUGH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15577204 ↗MalfunctionOct 11, 2022Air/Gas in Device; Air/Gas in Device
PER CUSTOMER REPORT: THE CLINIC'S TECHNICIAN SAY WHEN THEY ARE DRAWING UP THE BLOOD WITH THESE SYRINGES THEY TEND TO GET AIR AND THEN WHEN PULLING BACK THE PLUNGER IT IS EXTREMELY FLIMSY AND BENDS. THE SEAL SEEMS TO BE FINE WITH THEM THOUGH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15575714 ↗MalfunctionAug 3, 2022Air/Gas in Device; Air/Gas in Device
THE CUSTOMER REPORTED WHEN THE TECHNICIANS ARE DRAWING THE BLOOD UP, THE SYRINGES TEND TO GET AIR AND THE PLUNGER IS EXTREMELY FLIMSY AND BENDS WHEN PULLING IT BACK. THE SEAL SEEMS TO BE FINE WITH THEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15157245 ↗MalfunctionJul 21, 2022Air/Gas in Device; Air/Gas in Device
THE CUSTOMER REPORTED WHEN THE TECHNICIANS ARE DRAWING THE BLOOD UP, THE SYRINGES TEND TO GET AIR AND THE PLUNGER IS EXTREMELY FLIMSY AND BENDS WHEN PULLING IT BACK. THE SEAL SEEMS TO BE FINE WITH THEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15074372 ↗MalfunctionApr 20, 2021Difficult to Advance; Difficult to Advance
CUSTOMER REPORTS: PLUNGERS ARE HARD TO PULL AND GET STUCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11693864 ↗MalfunctionMar 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT ROUGHLY 1 IN 6 SYRINGES THE NEEDLES ARE NOT PROPERLY SEATED AND THEY ARE STUCK IN THE CAP. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER STATED THAT THE NEEDLE HAS DETACHED FROM THE HUB AND STUCK IN THE CAP. THE NEEDLE WAS NOT BENT. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11407025 ↗MalfunctionFeb 3, 2021Component Incompatible; Component Incompatible
THE CUSTOMER REPORTED THAT THE SYRINGES WERE RECEIVED WITH NO SUCTION. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER STATED THAT THE ISSUE SEEMS TO BE THAT THE PLUNGERS DID NOT FIT THE BARRELS CORRECTLY, CAUSING LOSS OF SUCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11276942 ↗MalfunctionFeb 1, 2021Physical Resistance/Sticking; Physical Resistance/Sticking
THE CUSTOMER REPORTED THAT THE PLUNGER WAS STICKING WHEN PULLING IT BACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11261143 ↗MalfunctionSep 15, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
THE CUSTOMER REPORTED WHEN THE VETERINARY TECH DREW UP MEDICATION THE CLEAR LIQUID TURNED CLOUDY/MILKY. HE DREW UP ANOTHER DOSE IN A SECOND SYRINGE AND IT WAS ALSO CLOUDY. THE CUSTOMER THOUGHT IT MIGHT BE THE DRUG BUT WHEN THE TECH WENT TO DRAW UP A DIFFERENT MEDICATION IN ANOTHER SYRINGE, IT WAS ALSO CLOUDY. THE TECH THEN DREW UP SOME STERILE WATER IN ANOTHER SYRINGE AND THE STERILE WATER ALSO TURNED CLOUDY.
Patient problems: No Patient Involvement
MAUDE report 10537353 ↗MalfunctionMar 6, 2020Nonstandard Device; Device Markings/Labelling Problem; Nonstandard Device; Device Markings/Labelling Problem
THE CUSTOMER REPORTED THAT THE SYRINGES ARE NOT HOLDING VACUUM AND THE EXPIRATION DATE COULD NOT BE LOCATED ON THE PRODUCT. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9799970 ↗MalfunctionFeb 19, 2020Nonstandard Device; Nonstandard Device
UPON INVESTIGATION AT THE MANUFACTURING PLANT, TWO SYRINGES PROVIDED FOR ANALYSIS FROM A CUSTOMER WERE DISCOVERED TO HAVE VARYING DEGREES OF SMEARED/ILLEGIBLE AND MISSING BARREL PRINT AND GRADUATION MARKS.
Patient problems: No Patient Involvement
MAUDE report 9727188 ↗MalfunctionDec 12, 2019Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking
THE CUSTOMER REPORTED THAT THE NEEDLE FELL OFF AND THE PLUNGER WAS DIFFICULT TO MOVE. THIS OCCURRED MULTIPLE TIMES BEFORE USE AND AFTER USE ON THE VETERINARY PATIENTS. NO INJURY OCCURRED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9457798 ↗MalfunctionNov 19, 2019Physical Resistance/Sticking; Physical Resistance/Sticking
THE CUSTOMER REPORTED TO THE DISTRIBUTOR THAT THE PLUNGERS ARE VERY STICKY AND VERY HARD TO BOTH PULL BACK AND TO EXPEL.
Patient problems: No Patient Involvement
MAUDE report 9340873 ↗MalfunctionNov 13, 2019Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED THAT THE PLUNGER WAS STICKING. IT WAS VERY DIFFICULT TO DRAW BLOOD AND ITS COLLAPSING THE VEIN. NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9315479 ↗MalfunctionNov 13, 2019Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED THAT THE PLUNGER WAS STICKING. IT WAS VERY DIFFICULT TO DRAW BLOOD AND ITS COLLAPSING THE VEIN. NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9315113 ↗MalfunctionOct 30, 2019Physical Resistance/Sticking; Physical Resistance/Sticking
THE CUSTOMER REPORTED THAT THE PLUNGERS WERE STICKING MAKING THEM DIFFICULT TO USE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9256765 ↗MalfunctionOct 15, 2019Physical Resistance/Sticking; Physical Resistance/Sticking
THE CUSTOMER REPORTED THAT THE PLUNGERS ARE STICKY WHICH IS VERY HARD TO DRAW BLOOD OR GIVE INJECTIONS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9191081 ↗MalfunctionOct 4, 2019Crack; Physical Resistance/Sticking; Crack; Physical Resistance/Sticking
THE CUSTOMER REPORTED THAT IT IS MUCH HARDER THAN USUAL TO DRAW PLUNGER BACK IN THE SYRINGE TO DRAW UP INJECTABLES, ALSO THE SYRINGE PART IS SOMETIMES CRACKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9158109 ↗MalfunctionSep 4, 2019Mechanical Jam; Mechanical Jam
THE CUSTOMER REPORTED THE PLUNGER PORTION ON THE SYRINGES STICK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8960962 ↗MalfunctionAug 19, 2019Mechanical Jam; Mechanical Jam
THE CUSTOMER REPORTED THAT THE PLUNGERS GET STUCK WHEN THEY TRY TO PULL IT OUT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8906578 ↗MalfunctionAug 2, 2019Nonstandard Device; Nonstandard Device
THE CUSTOMER REPORTED THAT THE PLUNGER IS STICKY AND HARD TO PULL BACK.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8854593 ↗MalfunctionJul 18, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE SYRINGES ARE LEAKING AT THE BASE OF THE HUB. THERE WAS NO HARM TO THE PATIENT OR STAFF.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8802151 ↗MalfunctionJun 21, 2019Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component
THE CUSTOMER STATES THE NEEDLES ARE NOT SECURELY ATTACHED TO THE SYRINGE WHEN REMOVED FROM THE BOX AND THE NEEDLE LOOKS BENT. WHEN THEY TRY TO REMOVE THE NEEDLE TO REPLACE IT, THE HUB CRACKS AND THE NEEDLE DETACHES. THIS WAS NOTICED BEFORE USE.
Patient problems: No Patient Involvement
MAUDE report 8723042 ↗MalfunctionJun 21, 2019Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component
THE CUSTOMER STATES THE NEEDLES ARE NOT SECURELY ATTACHED TO THE SYRINGE WHEN REMOVED FROM THE BOX AND THE NEEDLES LOOK BENT. WHEN THEY TRY TO REMOVE THE NEEDLE TO REPLACE IT, THE HUB CRACKS AND THE NEEDLE DETACHES. THIS WAS NOTICED BEFORE USE.
Patient problems: No Patient Involvement
MAUDE report 8722992 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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