Monoject 1181200777T (UDI 10884521179233)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521179233), received between Dec 17, 2021 and Feb 7, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Disintegration” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2025Material Disintegration; Material Disintegration

  THE CUSTOMER REPORTED A SYRINGE WITH RESIDUALS AFTER INFUSION OF DEXTROSE. NO PATIENT HARM, MEDICAL INTERVENTION OR HOSPITALIZATION. ADDITIONAL DEVICES USED: BBRAUN PERFUSOR SPACE SYRINGE PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21339917 ↗
• MalfunctionFeb 7, 2025Material Disintegration; Material Disintegration

  THE CUSTOMER REPORTED A SYRINGE WITH RESIDUALS AFTER INFUSION OF DEXTROSE. NO PATIENT HARM, MEDICAL INTERVENTION OR HOSPITALIZATION. ADDITIONAL DEVICES USED: BBRAUN PERFUSOR SPACE SYRINGE PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21339853 ↗
• MalfunctionFeb 7, 2025Material Disintegration; Material Disintegration

  THE CUSTOMER REPORTED THAT THE 12ML SYRINGE HAS RESIDUALS AFTER THE INFUSION OF THE MEDICATION. OTHER SYRINGES SO FAR HAD NO ISSUES WITH RESIDUALS BEFORE BUT A FEW MONTHS AGO THEY HAD THE SAME ISSUE WITH 12MLS. THEY ARE NOT SURE IF IT IS THE SYRINGE OR THE PUMP THAT IS CAUSING THE RESIDUALS. PHOTOS ATTACHED. ADDITIONAL INFORMATION RECEIVED ON 27DEC2024 STATED THAT THE STAFF IN NICU HAS NOTED THAT ONLY THE 12ML SYRINGE OF IV MEDICATION HAS RESIDUALS. THIS SYRINGE IS NOT COMING FROM THE NICU BB BUT FROM PHARMACY AS THE MEDICATION COMES PREFILLED FROM THEM. THIS 12ML MEDICATION SYRINGE IS ONLY BEING USED IN THE PUMP DURING MEDICATION ADMINISTRATION. THE PUMP BEING USED IS THE BRAUN INFUSOMAT SYRINGE PUMP - NO OTHER ISSUES WITH OTHER SYRINGE INFUSION. THE USUAL MEDICATION INFUSED ON THE 12ML IN THEIR UNIT IS GENTAMICIN. AMOUNT OF MEDICATION VARIES WITH EACH WEIGHT SPECIFIC DOSE BUT RESIDUALS SEEMS TO BE CONSISTENT BETWEEN 1-1.5ML. THE PUMP INDICATES THAT THE INFUSION HAS BEEN COMPLETED. THERE WAS NO HARM TO THE PATIENT BUT STAFF NEEDS TO OVERRIDE AND RE-INFUSE THE REMAINING DOSE/ PUSH RESIDUAL THROUGH TUBING EXTENSION SET BEFORE INFUSING THE SALINE TO FLUSH MEDICATION EXTENSION TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21339814 ↗
• MalfunctionFeb 7, 2025Material Disintegration; Material Disintegration

  THE CUSTOMER REPORTED THAT THE 12ML SYRINGE HAS RESIDUALS AFTER THE INFUSION OF THE MEDICATION. OTHER SYRINGES SO FAR HAD NO ISSUES WITH RESIDUALS BEFORE BUT A FEW MONTHS AGO THEY HAD THE SAME ISSUE WITH 12MLS. THEY ARE NOT SURE IF IT IS THE SYRINGE OR THE PUMP THAT IS CAUSING THE RESIDUALS. PHOTOS ATTACHED. ADDITIONAL INFORMATION RECEIVED ON 27DEC2024 STATED THAT THE STAFF IN NICU HAS NOTED THAT ONLY THE 12ML SYRINGE OF IV MEDICATION HAS RESIDUALS. THIS SYRINGE IS NOT COMING FROM THE NICU BB BUT FROM PHARMACY AS THE MEDICATION COMES PREFILLED FROM THEM. THIS 12ML MEDICATION SYRINGE IS ONLY BEING USED IN THE PUMP DURING MEDICATION ADMINISTRATION. THE PUMP BEING USED IS THE BRAUN INFUSOMAT SYRINGE PUMP - NO OTHER ISSUES WITH OTHER SYRINGE INFUSION. THE USUAL MEDICATION INFUSED ON THE 12ML IN THEIR UNIT IS GENTAMICIN. AMOUNT OF MEDICATION VARIES WITH EACH WEIGHT SPECIFIC DOSE BUT RESIDUALS SEEMS TO BE CONSISTENT BETWEEN 1-1.5ML. THE PUMP INDICATES THAT THE INFUSION HAS BEEN COMPLETED. THERE WAS NO HARM TO THE PATIENT BUT STAFF NEEDS TO OVERRIDE AND RE-INFUSE THE REMAINING DOSE/ PUSH RESIDUAL THROUGH TUBING EXTENSION SET BEFORE INFUSING THE SALINE TO FLUSH MEDICATION EXTENSION TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21339713 ↗
• MalfunctionApr 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  CUSTOMER REPORTS: AN INCIDENT HAPPENED ON THE EVENING OF (B)(6) 2023 INVOLVING 12-ML SYRINGES THAT WERE USED BY THE NURSE WHILE DRAWING BLOOD FROM A VENOUS SHEATH ON A NEW ADMITTANCE IN ROOM 2722. THE LUER LOCK OF TWO 12-ML SYRINGES BROKE OFF DURING ROUTINE HANDLING OF THE ITEMS. THE 1ST SYRINGE HAD A BLUNT NEEDLE ATTACHED TO IT. WHEN THE NURSE UNSCREWED THE NEEDLE, THE LUER LOCK CAME WITH IT. THE 1ST SYRINGE WAS USED TO DRAW BLOOD AND HAD NO ISSUES WHEN UNSCREWED FROM THE PORT OF THE VENOUS SHEATH. THE 2ND SYRINGE WAS USED TO DRAW BLOOD FROM THE SAME PORT AND WHEN UNSCREWED, THE LUER LOCK BROKE OFF AND REMAINED STUCK INSIDE THE PORT. THERE WERE NO FURTHER ISSUES REPORTED RELATED TO THE USE OF OTHER 12-ML SYRINGES FOR THE REST OF THE SHIFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16762169 ↗
• MalfunctionAug 11, 2022Break; Break

  THE CUSTOMER REPORTED THE TIP IS BREAKING OFF IN THE IV CONNECTING TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15209296 ↗
• MalfunctionAug 10, 2022Break; Break

  THE CUSTOMER REPORTED THAT THE SYRINGE TIP BREAKS OFF IN THE INTRAVENOUS (IV) CONNECTING TUBING. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15201238 ↗
• MalfunctionDec 17, 2021Break; Break

  THE CUSTOMER REPORTED THAT THE TIP OF THE LUER LOCK SYRINGES WERE BREAKING OFF IN THE TUBING CONNECTION. THE CUSTOMER HAS WORKED WITH THE PHARMACY AND NEWBORN INTENSIVE CARE UNIT (NICU) TO INVESTIGATE THIS ISSUE. PER CUSTOMER, AT FIRST, THEY THOUGHT IT WAS ASSOCIATED WITH AN ANTIBIOTIC BEING INFUSED THROUGH THE MICROBORE TUBING BUT THEY CAME TO FIND OUT THIS IS HAPPENING WITH ALL DIFFERENT MEDICATIONS. THE CUSTOMER FURTHER STATED THAT WHEN THIS ISSUE OCCURS, THE NURSE CANNOT FLUSH THE REMAINING ANTIBIOTICS INTO THE NEONATES. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THIS IS THE FIRST TIME THE CUSTOMER REPORTING THIS ISSUE TO CARDINAL HEALTH, AS THE CUSTOMER HAD A TASK FORCE INVESTIGATING THIS ISSUE AND HAVE RULED OUT OTHER POSSIBLE REASONS FOR THIS OCCURRING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13025157 ↗