MaxGuard ME1021Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885403235955), received between Sep 28, 2018 and Aug 25, 2026 — classified as 1 injury, 7 malfunctions.

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

• MalfunctionAug 25, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50422105 ↗
• InjuryApr 16, 2020Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT WHICH STATES, "THE RN WAS IN THE PATIENT ROOM NEXT TO THE PATIENT'S BED. THE PATIENT SAT IN HIS MOM'S LAP ON THE PATIENT BED AND IT WAS AT THIS TIME THAT THIS RN NOTICED THAT THE TPN TUBING HAD BECOME DISCONNECTED FROM THE PATIENT'S PICC TRIFUSE AND WAS LYING ON THE BED. THIS RN CLAMPED THE TRIFUSE, PAUSED THE TPN, AND NOTIFIED THE CHARGE NURSE AND THE PROVIDER. THE PROVIDER TOLD THIS RN THAT HE/SHE WOULD ORDER FLUIDS TO REPLACE THE TPN. THE PATIENT WAS SITTING CALMLY WITH MOM M THE CHAIR. THIS RN LIFTED UP THE REMAINING TUBING WITH LIPIDS RUNNING NOTICED THAT THE LIPID TUBING HAD JUST BEEN DISCONNECTED FROM THE TRIFUSE AS WELL. THIS RN NOTIFIED THE PROVIDER AND THE CHARGE NURSE. PATIENT LATER DEVELOPED CLABSI AND IS BEING TREATED. HOWEVER, WE HAVE NOT IDENTIFIED A CONFIRMED LINK BETWEEN THE CLABSI AND THE TRIFUSE TUBING. THE RN WAS ABLE TO EASILY PULL APART THE TNFUSE TUBING. SHE GRASPED THE CLEAR HUB AND THE OTHER END OF THE TUBING WHERE IT BRANCHES INTO THE THREE STEMS AND WITH A LITTLE BIT OF FORCE, WAS ABLE TO PULL IT APART. THE TUBING ITSELF DOES NOT TEAR APART OR STRETCH. INSTEAD, THE TUBING PULLS AWAY FROM

  Patient problems: Unspecified Infection

  MAUDE report 9967463 ↗
• MalfunctionJul 15, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT IN THE NICU, THE RN NOTED BLOOD IN THE BED AND BLOOD BACKING UP IN THE TUBING. THE MEDICATION LINE WAS CLAMPED, AND THE LEAKAGE WAS FOUND TO BE AT THE "CLC" CONNECTION TO THE MEDICATION LINE, AND ALSO WHERE THE MEDICATION LINE ATTACHED TO THE Y-SITE. THE ENTIRE TUBING SET WAS CHANGED. THIS WAS REPORTED AS AN "UNSAFE CONDITION (NON EVENT)". ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 8791409 ↗
• MalfunctionOct 23, 2018Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE CUSTOMER REPORTED A GENERALIZED RECURRING PRODUCT CONCERN IN WHICH THE MALE LUER IS UNABLE TO BE DISCONNECTED AND BECOMES STUCK INSIDE THE VALVE OR THE FEMALE LUER OF THE MATING DEVICE THAT IT IS CONNECTED TO. THE NURSING STAFF HAVE RESORTED TO ATTEMPTING TO REMOVE THE TUBING SET FROM THE PATIENT WHILE USING HEMOSTATS ONLY TO HAVE THE MALE LUER BREAK OFF. THE CUSTOMER FURTHER STATES THAT THEY DO NOT USE ALCOHOL ON THE MALE LUER WHEN THEY CONNECT THE SETS TOGETHER. THE NURSE WILL PRIME THE SET WITH THE FLUID THAT WILL BE DELIVERED AND THEN CONNECT THE SYRINGE TO THE SET AND PRIME UNTIL THE FLUID EXITS AT THE MALE LUER WITH THE DUCT CAP STILL ATTACHED., THIS IS ALSO DONE FOR DEXTROSE AS WELL. BEFORE THE NURSE CONNECTS THE MALE LUER TO AN OPEN FEMALE LUER, THE NURSE WILL USE A PREFILLED SYRINGE TO PLACE SALINE INTO THE FEMALE LUER BEFORE CONNECTION TO ENSURE THAT AN AIR BUBBLE IS NOT INTRODUCED. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7997140 ↗
• MalfunctionSep 28, 2018Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE PATIENT HAD A DOUBLE LUMEN RIGHT INTERNAL JUGULAR CENTRAL VENOUS LINE (RIJ CVL) WITH A MAXGUARD TRIFUSE EXTENSION SET CONNECTED TO IT VIA A NON-BD NEEDLELESS CONNECTOR . THE TRIFUSE EXTENSION SET THEN HAD THREE NON-BD SMALLBORE FILTERED EXTENSION SETS ATTACHED TO EACH ARM ON THE TRIFUSE SET, INFUSING MILRINONE, HEPARIN 5,000U/50ML AND HEPARIN 1/2 NS. WHEN THE TRIFUSE EXTENSION SET WAS DISCONNECTED FROM THE NON-BD NEEDLELESS CONNECTOR, THE MALE LUER ON THE TRI-FUSE BROKE OFF IN THE NON-BD NEEDLELESS CONNECTOR AND BLOOD LEAKED ONTO THE PATIENT'S BED. THE CVL WAS CLAMPLED AND THE NEEDLELESS CONNECTOR WAS REMOVED. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7920707 ↗
• MalfunctionSep 28, 2018Break; Fluid/Blood Leak; Physical Resistance/Sticking; Break; Fluid/Blood Leak; Physical Resistance/Sticking

  THE CUSTOMER REPORTED A GENERALIZED RECURRING PRODUCT CONCERN IN WHICH THE MALE LUER IS UNABLE TO BE DISCONNECTED AND BECOMES STUCK INSIDE THE VALVE OR THE FEMALE LUER THAT IT IS CONNECTED TO. THE NURSING STAFF HAVE RESORTED TO ATTEMPTING TO REMOVE THE TUBING SET FROM THE PATIENT WHILE USING HEMOSTATS ONLY TO HAVE THE MALE LUER BREAK OFF. IN ONE PATIENT EXAMPLE, THE MALE LUER WAS STUCK INSIDE THE VALVE AND BROKE CLEANLY OFF FROM THE INSIDE OF THE SPIN COLLAR. THE NURSE COULD NOT REMEMBER WHAT MEDICATION WAS INFUSING AT THE TIME, HOWEVER, DOES RECALL THAT THE PATIENT LOST A NEGLIGIBLE AMOUNT OF BLOOD DUE TO HAVING TO CHANGE OUT THE ENTIRE SET-UP ALL THE WAY DOWN TO THE PATIENT'S IV HUB. THE PATIENT DID NOT REQUIRE HAVING A NEW IV SITE INSERTED DUE TO THE EVENT. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 7920620 ↗
• MalfunctionSep 28, 2018Material Separation; Physical Resistance/Sticking; Material Separation; Physical Resistance/Sticking

  THE CUSTOMER REPORTED A GENERALIZED RECURRING PRODUCT CONCERN IN WHICH THE MALE LUER IS UNABLE TO BE DISCONNECTED AND BECOMES STUCK INSIDE THE VALVE OR THE FEMALE LUER OF THE MATING DEVICE THAT IT IS CONNECTED TO. THE NURSING STAFF HAVE RESORTED TO ATTEMPTING TO REMOVE THE TUBING SET FROM THE PATIENT WHILE USING HEMOSTATS ONLY TO HAVE THE MALE LUER BREAK OFF. THE SECOND PATIENT EXAMPLE PROVIDED BY THE CUSTOMER REPORTED THAT WHEN THE NURSE WAS CHANGING THE INFUSIONS, SHE WAS UNABLE TO GET THE TWO TRI-FUSE TUBING SETS TO SEPARATE FROM ONE ANOTHER. THE NURSE ATTEMPTED TO USE HEMOSTATS TO DISCONNECT THE TWO SETS, BUT THE TUBING SEPARATED AND THE MALE LUER REMAINED STUCK. THERE WAS MILRINONE AND HEPARIN INFUSING AT THE TIME. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7920583 ↗
• MalfunctionSep 28, 2018Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE CUSTOMER REPORTED THAT WHEN THE NURSE WAS DISCONNECTING THE TRIFUSE TUBING SET FROM THE PATIENT'S PICC LINE, THE TRIFUSE MALE LUER BROKE OFF AND WAS STUCK IN THE BBRAUN CARESITE POSIFLOW. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7920204 ↗