Monoject 1182000777 (UDI 10884521010802)Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10884521010802), received between Aug 6, 2019 and Feb 18, 2025 — classified as 12 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (16 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 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE SYRINGE PLUNGER SEAL IS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21393612 ↗
• MalfunctionSep 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THERE IS LEAKAGE PAST THE STOPPER OF THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20295167 ↗
• MalfunctionApr 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT WHILE MIXING FOR NON-HD COMPOUNDS, COMPOUNDING PHARMACY TECHNICIAN NOTICED A COUPLE SYRINGES HAD A BAD SEAL ON THE BLACK PLUNGER OF THE MONOJECT 20ML SYRINGE CAUSING MEDICATION TO LEAK OUT OF THE SYRINGE ONCE HE STARTED TO WITHDRAW. THE ITEM WAS MONOJECT 20 ML SYRINGE LUER-LOCK TIP, REFERENCE NUMBER: 1182000777, LOT NUMBER: 314254X. THIS DID NOT AFFECT PATIENT CARE AS THE CORRECT VOLUME WAS WITHDRAWN WITH A NEW SYRINGE FOR COMPOUNDING. MULTIPLE SYRINGES WITH THE SAME LOT NUMBER WERE TESTED USING NON-DRUG DILUENTS, AND LEAKAGE WAS OBSERVED. IDENTICAL PRODUCTS WITH MATCHING LOT NUMBER WERE REMOVED AND WAS NOT FURTHER USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19041349 ↗
• MalfunctionJan 8, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE PLUNGER SEAL BROKEN WITH MEDICATION LEAKING OUT THE BACK SIDE. 2 OUT OF 4 SYRINGES. RESULTED IN DELAY OF CARE AND WASTE OF MEDS AND CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18471468 ↗
• MalfunctionJan 8, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE RUBBER TIP INSIDE THE BARREL IS WARPED. DRUG IS SPRAYING OUT THE BACK WHEN INJECTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18471118 ↗
• MalfunctionNov 16, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THE ITEM IS LEAKING ON THE TOP WHEN THE SYRINGE IS USED.ADDITIONAL INFORMATION RECEIVED STATED IT IS LEAKING OUT OF THE CONNECTION OF THE LUER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18149168 ↗
• InjuryNov 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED ANONYMOUSLY VIA MEDWATCH THAT THE CUSTOMER RECENTLY PURCHASED CARDINAL MONOJECT SYRINGES AND THE OR HAS REPORTED DOSING ERRORS (DECREASED DOSE/RATE) WHILE USING THESES SYRINGES IN THEIR OR (MEDFUSION 4000) PUMPS. THEY TESTED THE 20 ML CARDINAL MONOJECT SYRINGES ON THEIR ALARIS PUMPS AND THEY WERE NOT RECOGNIZED. BOTH MANUFACTURERS HAVE BEEN CONTACTED REGARDING WHETHER OR NOT CARDINAL MONOJECT SYRINGES ARE COMPATIBLE WITH THEIR SYRINGE PUMPS AND THE CUSTOMER STATED THAT THEY HAVE BEEN INFORMED THAT ACCURACY OF THOSE SYRINGES HAS NOT BEEN ESTABLISHED AND THAT THEY SHOULD NOT USE ANY SIZE OF THE CARDINAL MONOJECT SYRINGES ON EITHER THE MEDFUSION OR ALARIS SYRINGE PUMPS. THEY BELIEVE THIS INITIALLY STARTED WHEN THE COVIDIEN MONOJECT SYRINGES WERE SUBSTITUTED BY THEIR DISTRIBUTOR. STILL TRYING TO DETERMINE BUT ARE PURCHASING BD SYRINGES. THERE ARE ONLY 3 BRANDS THAT ARE COMPATIBLE WITH ALARIS AND APPARENTLY THERE ARE REPORTS OF LEAKS WITH TERUMO SYRINGES AND COVIDIEN MONOJECT ARE NO LONGER MADE SO NOW ONLY ONE MANUFACTURER AVAILABLE THAT HAS SYRINGE COMPATIBILITY. WILL TRY TO LIMIT TO BD BRAND BUT NOT SURE HOW TO MANAGE IF THERE IS A SHORTAGE OF THOSE SYRINGES.

  Patient problems: Insufficient Information

  MAUDE report 18125215 ↗
• InjurySep 6, 2023Compatibility Problem; Adverse Event Without Identified Device or Use Problem; Compatibility Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THEY ARE USING THE CARDINAL HEALTH (CAH) BRAND SYRINGES IN THE ALARIS INFUSION PUMP AND EXPERIENCING MEDICATION DELIVERING FASTER THAN IT SHOULD. FOR EXAMPLE, IF THE PUMP IS SET TO INFUSE OVER 13 HOURS, IT IS DELIVERING MEDICATION IN 6-7 HOURS AS IT IS DETECTING INCORRECT VOLUMES IN THE PUMPS. EXAMPLE: THE PUMP IS DETECTING A VOLUME OF 7, BUT THERE IS ONLY A VOLUME OF 5, SO IT IS ADMINISTERING FASTER THAN SET AS THE PUMP BELIEVES THERE IS MORE MEDICATION TO DELIVER OVER THE PERIOD OF TIME. THIS HAS LED TO PATIENTS RECEIVING "LIFE SUSTAINING" MEDICATION TOO QUICKLY. THE CUSTOMER STATED THE PHARMACY DID THEIR OWN TESTING USING WATER IN THE CAH BRAND 3ML, 6ML, 20ML AND 35ML SYRINGES IN THE ALARIS PUMP AND EACH TIME THE PUMP DETECTED INCORRECT VOLUME, STATING 100% FAILURE RATE. THE HOSPITAL IS PULLING ALL CAH BRAND SYRINGES FROM THE FLOORS, STARTING WITH CRITICAL AREAS, AND WILL SEQUESTER PRODUCT FOR INVESTIGATION SAMPLES.

  Patient problems: Insufficient Information

  MAUDE report 17690888 ↗
• InjurySep 6, 2023Compatibility Problem; Adverse Event Without Identified Device or Use Problem; Compatibility Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THEY ARE USING THE CARDINAL HEALTH (CAH) BRAND SYRINGES IN THE ALARIS INFUSION PUMP AND EXPERIENCING MEDICATION DELIVERING FASTER THAN IT SHOULD. FOR EXAMPLE, IF THE PUMP IS SET TO INFUSE OVER 13 HOURS, IT IS DELIVERING MEDICATION IN 6-7 HOURS AS IT IS DETECTING INCORRECT VOLUMES IN THE PUMPS. EXAMPLE: THE PUMP IS DETECTING A VOLUME OF 7, BUT THERE IS ONLY A VOLUME OF 5, SO IT IS ADMINISTERING FASTER THAN SET AS THE PUMP BELIEVES THERE IS MORE MEDICATION TO DELIVER OVER THE PERIOD OF TIME. THIS HAS LED TO PATIENTS RECEIVING "LIFE SUSTAINING" MEDICATION TOO QUICKLY. THE CUSTOMER STATED THE PHARMACY DID THEIR OWN TESTING USING WATER IN THE CAH BRAND 3ML, 6ML, 20ML AND 35ML SYRINGES IN THE ALARIS PUMP AND EACH TIME THE PUMP DETECTED INCORRECT VOLUME, STATING 100% FAILURE RATE. THE HOSPITAL IS PULLING ALL CAH BRAND SYRINGES FROM THE FLOORS, STARTING WITH CRITICAL AREAS, AND WILL SEQUESTER PRODUCT FOR INVESTIGATION SAMPLES.

  Patient problems: Insufficient Information

  MAUDE report 17690832 ↗
• InjurySep 6, 2023Compatibility Problem; Adverse Event Without Identified Device or Use Problem; Compatibility Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THEY ARE USING THE CARDINAL HEALTH (CAH) BRAND SYRINGES IN THE ALARIS INFUSION PUMP AND EXPERIENCING MEDICATION DELIVERING FASTER THAN IT SHOULD. FOR EXAMPLE, IF THE PUMP IS SET TO INFUSE OVER 13 HOURS, IT IS DELIVERING MEDICATION IN 6-7 HOURS AS IT IS DETECTING INCORRECT VOLUMES IN THE PUMPS. EXAMPLE: THE PUMP IS DETECTING A VOLUME OF 7, BUT THERE IS ONLY A VOLUME OF 5, SO IT IS ADMINISTERING FASTER THAN SET AS THE PUMP BELIEVES THERE IS MORE MEDICATION TO DELIVER OVER THE PERIOD OF TIME. THIS HAS LED TO PATIENTS RECEIVING "LIFE SUSTAINING" MEDICATION TOO QUICKLY. THE CUSTOMER STATED THE PHARMACY DID THEIR OWN TESTING USING WATER IN THE CAH BRAND 3ML, 6ML, 20ML AND 35ML SYRINGES IN THE ALARIS PUMP AND EACH TIME THE PUMP DETECTED INCORRECT VOLUME, STATING 100% FAILURE RATE. THE HOSPITAL IS PULLING ALL CAH BRAND SYRINGES FROM THE FLOORS, STARTING WITH CRITICAL AREAS, AND WILL SEQUESTER PRODUCT FOR INVESTIGATION SAMPLES.

  Patient problems: Insufficient Information

  MAUDE report 17690698 ↗
• InjurySep 6, 2023Compatibility Problem; Adverse Event Without Identified Device or Use Problem; Compatibility Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THEY ARE USING THE CARDINAL HEALTH (CAH) BRAND SYRINGES IN THE ALARIS INFUSION PUMP AND EXPERIENCING MEDICATION DELIVERING FASTER THAN IT SHOULD. FOR EXAMPLE, IF THE PUMP IS SET TO INFUSE OVER 13 HOURS, IT IS DELIVERING MEDICATION IN 6-7 HOURS AS IT IS DETECTING INCORRECT VOLUMES IN THE PUMPS. EXAMPLE: THE PUMP IS DETECTING A VOLUME OF 7, BUT THERE IS ONLY A VOLUME OF 5, SO IT IS ADMINISTERING FASTER THAN SET AS THE PUMP BELIEVES THERE IS MORE MEDICATION TO DELIVER OVER THE PERIOD OF TIME. THIS HAS LED TO PATIENTS RECEIVING "LIFE SUSTAINING" MEDICATION TOO QUICKLY. THE CUSTOMER STATED THE PHARMACY DID THEIR OWN TESTING USING WATER IN THE CAH BRAND 3ML, 6ML, 20ML AND 35ML SYRINGES IN THE ALARIS PUMP AND EACH TIME THE PUMP DETECTED INCORRECT VOLUME, STATING 100% FAILURE RATE. THE HOSPITAL IS PULLING ALL CAH BRAND SYRINGES FROM THE FLOORS, STARTING WITH CRITICAL AREAS, AND WILL SEQUESTER PRODUCT FOR INVESTIGATION SAMPLES.

  Patient problems: Insufficient Information

  MAUDE report 17690675 ↗
• InjurySep 6, 2023Compatibility Problem; Adverse Event Without Identified Device or Use Problem; Compatibility Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THEY ARE USING THE CARDINAL HEALTH (CAH) BRAND SYRINGES IN THE ALARIS INFUSION PUMP AND EXPERIENCING MEDICATION DELIVERING FASTER THAN IT SHOULD. FOR EXAMPLE, IF THE PUMP IS SET TO INFUSE OVER 13 HOURS, IT IS DELIVERING MEDICATION IN 6-7 HOURS AS IT IS DETECTING INCORRECT VOLUMES IN THE PUMPS. EXAMPLE: THE PUMP IS DETECTING A VOLUME OF 7, BUT THERE IS ONLY A VOLUME OF 5, SO IT IS ADMINISTERING FASTER THAN SET AS THE PUMP BELIEVES THERE IS MORE MEDICATION TO DELIVER OVER THE PERIOD OF TIME. THIS HAS LED TO PATIENTS RECEIVING "LIFE SUSTAINING" MEDICATION TOO QUICKLY. THE CUSTOMER STATED THE PHARMACY DID THEIR OWN TESTING USING WATER IN THE CAH BRAND 3ML, 6ML, 20ML AND 35ML SYRINGES IN THE ALARIS PUMP AND EACH TIME THE PUMP DETECTED INCORRECT VOLUME, STATING 100% FAILURE RATE. THE HOSPITAL IS PULLING ALL CAH BRAND SYRINGES FROM THE FLOORS, STARTING WITH CRITICAL AREAS, AND WILL SEQUESTER PRODUCT FOR INVESTIGATION SAMPLES.

  Patient problems: Insufficient Information

  MAUDE report 17690635 ↗
• InjurySep 6, 2023Compatibility Problem; Adverse Event Without Identified Device or Use Problem; Compatibility Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THEY ARE USING THE CARDINAL HEALTH (CAH) BRAND SYRINGES IN THE ALARIS INFUSION PUMP AND EXPERIENCING MEDICATION DELIVERING FASTER THAN IT SHOULD. FOR EXAMPLE, IF THE PUMP IS SET TO INFUSE OVER 13 HOURS, IT IS DELIVERING MEDICATION IN 6-7 HOURS AS IT IS DETECTING INCORRECT VOLUMES IN THE PUMPS. EXAMPLE: THE PUMP IS DETECTING A VOLUME OF 7, BUT THERE IS ONLY A VOLUME OF 5, SO IT IS ADMINISTERING FASTER THAN SET AS THE PUMP BELIEVES THERE IS MORE MEDICATION TO DELIVER OVER THE PERIOD OF TIME. THIS HAS LED TO PATIENTS RECEIVING "LIFE SUSTAINING" MEDICATION TOO QUICKLY. THE CUSTOMER STATED THE PHARMACY DID THEIR OWN TESTING USING WATER IN THE CAH BRAND 3ML, 6ML, 20ML AND 35ML SYRINGES IN THE ALARIS PUMP AND EACH TIME THE PUMP DETECTED INCORRECT VOLUME, STATING 100% FAILURE RATE. THE HOSPITAL IS PULLING ALL CAH BRAND SYRINGES FROM THE FLOORS, STARTING WITH CRITICAL AREAS, AND WILL SEQUESTER PRODUCT FOR INVESTIGATION SAMPLES.

  Patient problems: Insufficient Information

  MAUDE report 17690603 ↗
• InjurySep 6, 2023Compatibility Problem; Adverse Event Without Identified Device or Use Problem; Compatibility Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THEY ARE USING THE CARDINAL HEALTH (CAH) BRAND SYRINGES IN THE ALARIS INFUSION PUMP AND EXPERIENCING MEDICATION DELIVERING FASTER THAN IT SHOULD. FOR EXAMPLE, IF THE PUMP IS SET TO INFUSE OVER 13 HOURS, IT IS DELIVERING MEDICATION IN 6-7 HOURS AS IT IS DETECTING INCORRECT VOLUMES IN THE PUMPS. EXAMPLE: THE PUMP IS DETECTING A VOLUME OF 7, BUT THERE IS ONLY A VOLUME OF 5, SO IT IS ADMINISTERING FASTER THAN SET AS THE PUMP BELIEVES THERE IS MORE MEDICATION TO DELIVER OVER THE PERIOD OF TIME. THIS HAS LED TO PATIENTS RECEIVING "LIFE SUSTAINING" MEDICATION TOO QUICKLY. THE CUSTOMER STATED THE PHARMACY DID THEIR OWN TESTING USING WATER IN THE CAH BRAND 3ML, 6ML, 20ML AND 35ML SYRINGES IN THE ALARIS PUMP AND EACH TIME THE PUMP DETECTED INCORRECT VOLUME, STATING 100% FAILURE RATE. THE HOSPITAL IS PULLING ALL CAH BRAND SYRINGES FROM THE FLOORS, STARTING WITH CRITICAL AREAS, AND WILL SEQUESTER PRODUCT FOR INVESTIGATION SAMPLES.

  Patient problems: Insufficient Information

  MAUDE report 17690479 ↗
• InjurySep 6, 2023Compatibility Problem; Adverse Event Without Identified Device or Use Problem; Compatibility Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THEY ARE USING THE CARDINAL HEALTH (CAH) BRAND SYRINGES IN THE ALARIS INFUSION PUMP AND EXPERIENCING MEDICATION DELIVERING FASTER THAN IT SHOULD. FOR EXAMPLE, IF THE PUMP IS SET TO INFUSE OVER 13 HOURS, IT IS DELIVERING MEDICATION IN 6-7 HOURS AS IT IS DETECTING INCORRECT VOLUMES IN THE PUMPS. EXAMPLE: THE PUMP IS DETECTING A VOLUME OF 7, BUT THERE IS ONLY A VOLUME OF 5, SO IT IS ADMINISTERING FASTER THAN SET AS THE PUMP BELIEVES THERE IS MORE MEDICATION TO DELIVER OVER THE PERIOD OF TIME. THIS HAS LED TO PATIENTS RECEIVING "LIFE SUSTAINING" MEDICATION TOO QUICKLY. THE CUSTOMER STATED THE PHARMACY DID THEIR OWN TESTING USING WATER IN THE CAH BRAND 3ML, 6ML, 20ML AND 35ML SYRINGES IN THE ALARIS PUMP AND EACH TIME THE PUMP DETECTED INCORRECT VOLUME, STATING 100% FAILURE RATE. THE HOSPITAL IS PULLING ALL CAH BRAND SYRINGES FROM THE FLOORS, STARTING WITH CRITICAL AREAS, AND WILL SEQUESTER PRODUCT FOR INVESTIGATION SAMPLES.

  Patient problems: Insufficient Information

  MAUDE report 17690412 ↗
• InjurySep 6, 2023Compatibility Problem; Adverse Event Without Identified Device or Use Problem; Compatibility Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THEY ARE USING THE CARDINAL HEALTH (CAH) BRAND SYRINGES IN THE ALARIS INFUSION PUMP AND EXPERIENCING MEDICATION DELIVERING FASTER THAN IT SHOULD. FOR EXAMPLE, IF THE PUMP IS SET TO INFUSE OVER 13 HOURS, IT IS DELIVERING MEDICATION IN 6-7 HOURS AS IT IS DETECTING INCORRECT VOLUMES IN THE PUMPS. EXAMPLE: THE PUMP IS DETECTING A VOLUME OF 7, BUT THERE IS ONLY A VOLUME OF 5, SO IT IS ADMINISTERING FASTER THAN SET AS THE PUMP BELIEVES THERE IS MORE MEDICATION TO DELIVER OVER THE PERIOD OF TIME. THIS HAS LED TO PATIENTS RECEIVING "LIFE SUSTAINING" MEDICATION TOO QUICKLY. THE CUSTOMER STATED THE PHARMACY DID THEIR OWN TESTING USING WATER IN THE CAH BRAND 3ML, 6ML, 20ML AND 35ML SYRINGES IN THE ALARIS PUMP AND EACH TIME THE PUMP DETECTED INCORRECT VOLUME, STATING 100% FAILURE RATE. THE HOSPITAL IS PULLING ALL CAH BRAND SYRINGES FROM THE FLOORS, STARTING WITH CRITICAL AREAS, AND WILL SEQUESTER PRODUCT FOR INVESTIGATION SAMPLES.

  Patient problems: Insufficient Information

  MAUDE report 17690373 ↗
• InjurySep 6, 2023Compatibility Problem; Adverse Event Without Identified Device or Use Problem; Compatibility Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THEY ARE USING THE CARDINAL HEALTH (CAH) BRAND SYRINGES IN THE ALARIS INFUSION PUMP AND EXPERIENCING MEDICATION DELIVERING FASTER THAN IT SHOULD. FOR EXAMPLE, IF THE PUMP IS SET TO INFUSE OVER 13 HOURS, IT IS DELIVERING MEDICATION IN 6-7 HOURS AS IT IS DETECTING INCORRECT VOLUMES IN THE PUMPS. EXAMPLE: THE PUMP IS DETECTING A VOLUME OF 7, BUT THERE IS ONLY A VOLUME OF 5, SO IT IS ADMINISTERING FASTER THAN SET AS THE PUMP BELIEVES THERE IS MORE MEDICATION TO DELIVER OVER THE PERIOD OF TIME. THIS HAS LED TO PATIENTS RECEIVING "LIFE SUSTAINING" MEDICATION TOO QUICKLY. THE CUSTOMER STATED THE PHARMACY DID THEIR OWN TESTING USING WATER IN THE CAH BRAND 3ML, 6ML, 20ML AND 35ML SYRINGES IN THE ALARIS PUMP AND EACH TIME THE PUMP DETECTED INCORRECT VOLUME, STATING 100% FAILURE RATE. THE HOSPITAL IS PULLING ALL CAH BRAND SYRINGES FROM THE FLOORS, STARTING WITH CRITICAL AREAS, AND WILL SEQUESTER PRODUCT FOR INVESTIGATION SAMPLES.

  Patient problems: Insufficient Information

  MAUDE report 17690247 ↗
• InjurySep 6, 2023Compatibility Problem; Adverse Event Without Identified Device or Use Problem; Compatibility Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THEY ARE USING THE CARDINAL HEALTH (CAH) BRAND SYRINGES IN THE ALARIS INFUSION PUMP AND EXPERIENCING MEDICATION DELIVERING FASTER THAN IT SHOULD. FOR EXAMPLE, IF THE PUMP IS SET TO INFUSE OVER 13 HOURS, IT IS DELIVERING MEDICATION IN 6-7 HOURS AS IT IS DETECTING INCORRECT VOLUMES IN THE PUMPS. EXAMPLE: THE PUMP IS DETECTING A VOLUME OF 7, BUT THERE IS ONLY A VOLUME OF 5, SO IT IS ADMINISTERING FASTER THAN SET AS THE PUMP BELIEVES THERE IS MORE MEDICATION TO DELIVER OVER THE PERIOD OF TIME. THIS HAS LED TO PATIENTS RECEIVING "LIFE SUSTAINING" MEDICATION TOO QUICKLY. THE CUSTOMER STATED THE PHARMACY DID THEIR OWN TESTING USING WATER IN THE CAH BRAND 3ML, 6ML, 20ML AND 35ML SYRINGES IN THE ALARIS PUMP AND EACH TIME THE PUMP DETECTED INCORRECT VOLUME, STATING 100% FAILURE RATE. THE HOSPITAL IS PULLING ALL CAH BRAND SYRINGES FROM THE FLOORS, STARTING WITH CRITICAL AREAS, AND WILL SEQUESTER PRODUCT FOR INVESTIGATION SAMPLES.

  Patient problems: Insufficient Information

  MAUDE report 17690156 ↗
• MalfunctionAug 30, 2023Break; Break

  CUSTOMER REPORTS: THE SYRINGE IS BREAKING AT THE LUER END WHEN SCREWING INTO THE IV EXTENSION SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17650594 ↗
• MalfunctionJun 2, 2023Break; Break

  THE CUSTOMER REPORTED BROKEN SYRINGE TIPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17050151 ↗
• MalfunctionJun 2, 2023Break; Break

  THE CUSTOMER REPORTED BROKEN SYRINGE TIPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17050144 ↗
• MalfunctionJun 1, 2023Break; Break

  THE CUSTOMER REPORTED THE INABILITY TO REMOVE TAMPER EVIDENT CAPS AND SUBSEQUENTLY BREAKING THE TIP IN THE PROCESS OF TRYING TO GET IT OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17043565 ↗
• MalfunctionSep 14, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED LEAKING AROUND THE PLUNGER WHILE THE PRODUCT WAS BEING USED TO MIX NICARDIPINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15417239 ↗
• MalfunctionJun 23, 2022Break; Break

  THE CUSTOMER REPORTED THAT THE INNER PIECE IS BREAKING OFF AT THE LUER-LOCK END. THE THREADS STAY BUT THE INNER STRAIGHT PIECE BREAKS OFF. THEY WERE LOSING COSTLY MEDICATIONS AT THE SAME TIME AND HAD TO DISPOSE OF THE WHOLE SYRINGE AND MEDICATION. PER ADDITIONAL INFORMATION RECEIVED ON 01JUN2022, THERE WAS NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14786392 ↗
• MalfunctionJun 23, 2022Break; Break

  THE CUSTOMER REPORTED THAT THE INNER PIECE IS BREAKING OFF AT THE LUER-LOCK END. THE THREADS STAY BUT THE INNER STRAIGHT PIECE BREAKS OFF. THEY WERE LOSING COSTLY MEDICATIONS AT THE SAME TIME AND HAD TO DISPOSE OF THE WHOLE SYRINGE AND MEDICATION. PER ADDITIONAL INFORMATION RECEIVED ON 01JUN2022, THERE WAS NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14786391 ↗