Monoject 1183500777 (UDI 10192253034691)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10192253034691), received between Dec 8, 2022 and Apr 14, 2024 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Break” (12 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Dec 28, 2023Open, Classified

   Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

   Z-0856-2024 · Root cause: Process change control · Recall details · FDA record ↗

2. Sep 20, 2023Open, Classified

   Demonstrated recognition and compatibility issues with syringe infusion pumps.

   Z-0149-2024 · Root cause: Vendor change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORT THAT GRADUATED LINE IS EASILY DETACHED WEAK PLUNGER, NO SUCTION, DIFFICULT TO CONTROL THE INJECTION SPEED LIQUID LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102939 ↗
• MalfunctionApr 13, 2024Compatibility Problem; Compatibility Problem

  THE CUSTOMER REPORTED AN ERROR MESSAGE INDICATING "OCCLUDED" IS SHOWING ON THE ALARIS PUMP IN THE NICU DEPARTMENT. THE ALARIS PUMPS IN NICU HAVE THE LATEST UPDATE. THE OCCLUSION ALARM INDICATES INCREASED BACK PRESSURE SENSED WHILE INFUSING. THE TUBING HAS NOT CHANGED. THE CUSTOMER STATES THEY FILL THE SYRINGES BEFORE USE SO THEY ARE NOT OCCLUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102790 ↗
• MalfunctionApr 12, 2024Compatibility Problem; Compatibility Problem

  THE CUSTOMER REPORTED THAT CHAT IN NUCLEAR RADIOLOGY STATED THAT THE INJECTION PUMPS WERE NOT RECORDING THE CORRECT VOLUME. HE WOULD SETUP A SYRINGE WITH A 30 ML DOSE, BUT THE BD ALARIS SYRINGE PUMP WOULD SHOW A 32.5 VOLUME. HE WAS USING THE SAME SETUP AS HE ALWAYS DID: MONOJECT 35 ML. HE ALSO MENTIONED THAT HE GOT NEW SYRINGES, AND THAT THE NEW SYRINGES WERE EASIER TO OPERATE. AFTER DOING TEST WITH THE NEW SYRINGE, THE INITIAL REPORTER WAS ABLE TO CONFIRM ACROSS EVERY TEST POINT THAT THE NEW MONOJECT SYRINGES WERE CONSTANTLY ABOUT 2.4 TO 2.5 ML OFF (EXTRA)- THEY WOULD SETUP A 20 ML INJECTION, BUT THE BD ALARIS SHOWED 22.4 ML. THIS VARIANCE WAS CONSISTENT FOR 10,20, 30 AND 35 ML. SEE PIC FOR THE 20 ML SYRINGE SETUP- ON THE SCREEN IT SHOWS'AVAILABLE 22.4 ML' THEY RECALIBRATED THE SYRINGE PUMP, SAME RESULTS. THEY TRIED THE SYRINGE ON DIFFERENT SYRINGE PUMPS, SAME RESULT, SO THEY CAN RULE OUT A BAD SYRINGE PUMP. FOUND AN OLD SYRINGE. TESTED IT. IT WAS ACCURATE TO WITHIN A 0.2ML, WHICH IS JUST A DROP. SO THEY EXAMINED BOTH SYRINGES AND FOUND THAT THE NEW MONOJECT 35 ML SYRINGES HAVE A LONGER BARREL. SINCE THE BD ALARIS CALIBRATION IS DETERMINED FROM THE AMOUNT OF THE BARREL ABOVE THE Z

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19095668 ↗
• MalfunctionApr 12, 2024Compatibility Problem; Compatibility Problem

  CUSTOMER REPORTS: THE ANESTHESIOLOGIST IS REPORTING AN ISSUE WITH THE NEW CARDINAL HEALTH MONOJECT 35MM SYRINGE NOT WORKING WITH THE MEDFUSION 4000 IV PUMPS. ENGINEERING IS WORKING ON DETERMINING IF IT IS AN ISSUE WITH THE SETTINGS AND I WAS HOPING YOU COULD TELL ME IF I NEED TO HAVE PHARMACY RECONFIGURE THE PUMPS. I CALLED CPMC TO SEE IF THEY ARE EXPERIENCING ANY PROBLEMS, BUT THEY ARE USING A DIFFERENT PUMP.  (ALARIS)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19095054 ↗
• InjurySep 12, 2023Compatibility Problem; Compatibility Problem

  THE CUSTOMER REPORTED THAT MONOJECT 35ML SYRINGES ARE AN OPTION THAT IS ALLOWED IN THEIR CAREFUSION SYRINGE INFUSION PUMPS. THEY STOCK BOTH COVIDIEN MONOJECT 35ML AND CARDINAL MONOJECT 35ML. NEONATAL INTENSIVE CARE NURSES RECOGNIZED THAT THE CARDINAL VERSION WAS SLIGHTLY DIFFERENT, AND WHEN BOTH SYRINGES WERE PULLED BACK TO THE SAME VALUE, THE PLUNGER OF THE CARDINAL BRAND SYRINGE WAS EXTENDED FURTHER. THIS CAUSES THE PUMP TO OVERESTIMATE HOW MUCH MEDICATION IS LEFT IN THE SYRINGE. IN ADDITION, THIS MISMATCH IS LIKELY CAUSING ERRONEOUS DOSES TO BE ADMINISTERED (IF THE BARREL SIZE IS DIFFERENT ON THE INSIDE). WHILE THIS MAY BE IRRELEVANT IN MAJORITY OF PATIENT CARE SITUATIONS, IT IS VERY CONCERNING IN POPULATIONS THAT ARE RECEIVING VERY SMALL DOSES, LIKE THEIR NEONATES.

  Patient problems: Insufficient Information

  MAUDE report 17732674 ↗
• MalfunctionAug 2, 2023Break; Break

  THE CUSTOMER REPORTED THAT THE PATIENT WAS RECEIVING PRBC'S (PACKED RED BLOOD CELLS). THE PRBC'S WERE COMPLETED AND THE RN (REGISTERED NURSE) WENT TO FLUSH THE LINE WITH NS (NORMAL SALINE) AND NOTICED THE TIP OF THE SYRINGE WAS BROKEN OFF AND THE IV TUBING WAS MALFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17442639 ↗
• MalfunctionJul 12, 2023Break; Break

  THE CUSTOMER REPORTED THAT THE OUTER WALL OF THE LUER LOCK AREA OF THE SYRINGE IS BREAKING WHEN PUSHING SALINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17310460 ↗
• MalfunctionMar 15, 2023Break; Break

  THE CUSTOMER REPORTED BROKEN SYRINGE TIPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16547730 ↗
• MalfunctionMar 15, 2023Break; Break

  THE CUSTOMER REPORTED BROKEN SYRINGE TIPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16547322 ↗
• MalfunctionDec 9, 2022Break; Break

  THE CUSTOMER REPORTED THE 35ML LUER LOCK TIPS ARE BREAKING. SOME IN PIECES AND SOME COMPLETELY AT THE CONNECTION TO THE SYRINGE BARREL. THE PROBLEM HAS CAUSED MEDICATION WASTE. PER ADDITIONAL INFORMATION PROVIDED ON DECEMBER 07, 2022, THE MEDICATION USED AT THE TIME OF THE BREAKS IS VARIABLE BUT MOST COMMONLY IS CEFAZOLIN, CEFTRIAXONE, OR CEFEPIME. THERE HAS BEEN NO PATIENT OR USER HARM ASSOCIATED WITH THE BREAKS. THEY USE B BRAUN¿S RED TAMPER EVIDENT CAP TO CAP THESE SYRINGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15948157 ↗
• MalfunctionDec 9, 2022Break; Break

  THE CUSTOMER REPORTED THE 35ML LUER LOCK TIPS ARE BREAKING. SOME IN PIECES AND SOME COMPLETELY AT THE CONNECTION TO THE SYRINGE BARREL. THE PROBLEM HAS CAUSED MEDICATION WASTE. PER ADDITIONAL INFORMATION PROVIDED ON DECEMBER 07, 2022, THE MEDICATION USED AT THE TIME OF THE BREAKS IS VARIABLE BUT MOST COMMONLY IS CEFAZOLIN, CEFTRIAXONE, OR CEFEPIME. THERE HAS BEEN NO PATIENT OR USER HARM ASSOCIATED WITH THE BREAKS. THEY USE B BRAUN¿S RED TAMPER EVIDENT CAP TO CAP THESE SYRINGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15948155 ↗
• MalfunctionDec 8, 2022Break; Break

  THE CUSTOMER REPORTED THE 35ML LUER LOCK TIPS ARE BREAKING. SOME IN PIECES AND SOME COMPLETELY AT THE CONNECTION TO THE SYRINGE BARREL. THE PROBLEM HAS CAUSED MEDICATION WASTE. PER ADDITIONAL INFORMATION PROVIDED ON DECEMBER 07, 2022, THE MEDICATION USED AT THE TIME OF THE BREAKS IS VARIABLE BUT MOST COMMONLY IS CEFAZOLIN, CEFTRIAXONE, OR CEFEPIME. THERE HAS BEEN NO PATIENT OR USER HARM ASSOCIATED WITH THE BREAKS. THEY USE B BRAUN¿S RED TAMPER EVIDENT CAP TO CAP THESE SYRINGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15942860 ↗
• MalfunctionDec 8, 2022Break; Break

  THE CUSTOMER REPORTED THE 35ML LUER LOCK TIPS ARE BREAKING. SOME IN PIECES AND SOME COMPLETELY AT THE CONNECTION TO THE SYRINGE BARREL. THE PROBLEM HAS CAUSED MEDICATION WASTE. PER ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2022, THE MEDICATION USED AT THE TIME OF THE BREAKS IS VARIABLE BUT MOST COMMONLY IS CEFAZOLIN, CEFTRIAXONE, OR CEFEPIME. THERE HAS BEEN NO PATIENT OR USER HARM ASSOCIATED WITH THE BREAKS. THEY USE B BRAUN¿S RED TAMPER EVIDENT CAP TO CAP THESE SYRINGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15942676 ↗
• MalfunctionDec 8, 2022Break; Break

  THE CUSTOMER REPORTED THE 35ML LUER LOCK TIPS ARE BREAKING. SOME IN PIECES AND SOME COMPLETELY AT THE CONNECTION TO THE SYRINGE BARREL. THE PROBLEM HAS CAUSED MEDICATION WASTE. PER ADDITIONAL INFORMATION PROVIDED ON DECEMBER 07, 2022, THE MEDICATION USED AT THE TIME OF THE BREAKS IS VARIABLE BUT MOST COMMONLY IS CEFAZOLIN, CEFTRIAXONE, OR CEFEPIME. THERE HAS BEEN NO PATIENT OR USER HARM ASSOCIATED WITH THE BREAKS. THEY USE B BRAUN¿S RED TAMPER EVIDENT CAP TO CAP THESE SYRINGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15942591 ↗
• MalfunctionDec 8, 2022Break; Break

  THE CUSTOMER REPORTED THE 35ML LUER LOCK TIPS ARE BREAKING. SOME IN PIECES AND SOME COMPLETELY AT THE CONNECTION TO THE SYRINGE BARREL. THE PROBLEM HAS CAUSED MEDICATION WASTE. PER ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2022, THE MEDICATION USED AT THE TIME OF THE BREAKS IS VARIABLE BUT MOST COMMONLY IS CEFAZOLIN, CEFTRIAXONE, OR CEFEPIME. THERE HAS BEEN NO PATIENT OR USER HARM ASSOCIATED WITH THE BREAKS. THEY USE B BRAUN¿S RED TAMPER EVIDENT CAP TO CAP THESE SYRINGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15942572 ↗
• MalfunctionDec 8, 2022Break; Break

  THE CUSTOMER REPORTED THE 35ML LUER LOCK TIPS ARE BREAKING. SOME IN PIECES AND SOME COMPLETELY AT THE CONNECTION TO THE SYRINGE BARREL. THE PROBLEM HAS CAUSED MEDICATION WASTE. PER ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2022, THE MEDICATION USED AT THE TIME OF THE BREAKS IS VARIABLE BUT MOST COMMONLY IS CEFAZOLIN, CEFTRIAXONE, OR CEFEPIME. THERE HAS BEEN NO PATIENT OR USER HARM ASSOCIATED WITH THE BREAKS. THEY USE B BRAUN¿S RED TAMPER EVIDENT CAP TO CAP THESE SYRINGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15942499 ↗
• MalfunctionDec 8, 2022Break; Break

  THE CUSTOMER REPORTED THE 35ML LUER LOCK TIPS ARE BREAKING. SOME IN PIECES AND SOME COMPLETELY AT THE CONNECTION TO THE SYRINGE BARREL. THE PROBLEM HAS CAUSED MEDICATION WASTE. PER ADDITIONAL INFORMATION PROVIDED ON DECEMBER 07, 2022, THE MEDICATION USED AT THE TIME OF THE BREAKS IS VARIABLE BUT MOST COMMONLY IS CEFAZOLIN, CEFTRIAXONE, OR CEFEPIME. THERE HAS BEEN NO PATIENT OR USER HARM ASSOCIATED WITH THE BREAKS. THEY USE B BRAUN¿S RED TAMPER EVIDENT CAP TO CAP THESE SYRINGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15942441 ↗