MaxGuard ME1224Recalls & reported problems
BD Switzerland Sàrl · 6-IN STANDARDBORE TRI-FUSE SET · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This is a BD MaxGuard ME1224 Tri-Fuse set, tubing used to run fluids and drugs into a vein during surgery and intensive care. The 43 reports mostly describe fluid or blood leaking from the tubing, often where the three ports join, so medication sometimes spills instead of reaching the patient; one report mentions a break. No deaths and no injuries were reported. One open recall began in October 2023 because sets labeled as free of DEHP actually contained it.
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
- 43
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10885403236112), received between Aug 9, 2018 and Jul 23, 2021 — classified as 43 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (38 reports).
1 FDA recall record name this device's identifier, 1 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. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Oct 11, 2023Open, Classified
Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).
Z-0351-2024 · Root cause: Error in labeling · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak38
- Insufficient Device Problem Information7
- Leak/Splash2
- Break1
Patient problems
- No Consequences Or Impact To Patient26
- No Information13
- No Known Impact Or Consequence To Patient3
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 23, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE 6-IN STANDARDBORE TRI-FUSE SET EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE'VE HAD A CONSISTENT AMOUNT OF ISSUES WITH FLUID LEAKING FROM THE AREA WHERE THE 3 PORTS CONNECT TO ONE. MEDICATION IS PLACED INTO THIS CONNECTION DURING HEART SURGERY AND IS LEAKING ONTO A TOWEL INSTEAD OF MAKING IT INTO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12220908 ↗MalfunctionMar 17, 2020Fluid/Blood Leak; Insufficient Device Problem Information; Fluid/Blood Leak; Insufficient Device Problem Information
IT WAS REPORTED THAT THE TRIFUSE EXTENSION LEAKED WHEN ATTACHED TO A PRIMARY SET AND WHEN MATED TO A SYRINGE.THE EVENT OCCURRED IN THE ICU . ALTHOUGH REQUESTED THERE WAS NO ADDITIONAL EVENT DETAILS OR PATIENT IMPACT PROVIDED AT THIS TIME. THE CUSTOMER STATED THE LEAKS OCCURRED WHEN REMOVING THE EXTENSION SET FROM THE PACKAGE AND TESTING THE SET WITH A SYRINGE. A VIDEO ATTACHED TO FILE OF PRODUCT FAILURE LEAKS WHEN USING SYRINGE AND SLID CLAMP IS CLAMPED.
Patient problems: No Information
MAUDE report 9845958 ↗MalfunctionMar 17, 2020Fluid/Blood Leak; Insufficient Device Problem Information; Fluid/Blood Leak; Insufficient Device Problem Information
IT WAS REPORTED THAT THE TRIFUSE EXTENSION LEAKED WHEN ATTACHED TO A PRIMARY SET AND WHEN MATED TO A SYRINGE.THE EVENT OCCURRED IN THE ICU . ALTHOUGH REQUESTED THERE WAS NO ADDITIONAL EVENT DETAILS OR PATIENT IMPACT PROVIDED AT THIS TIME. THE CUSTOMER STATED THE LEAKS OCCURRED WHEN REMOVING THE EXTENSION SET FROM THE PACKAGE AND TESTING THE SET WITH A SYRINGE. A VIDEO ATTACHED TO FILE OF PRODUCT FAILURE LEAKS WHEN USING SYRINGE AND SLID CLAMP IS CLAMPED .
Patient problems: No Information
MAUDE report 9845956 ↗MalfunctionMar 17, 2020Fluid/Blood Leak; Insufficient Device Problem Information; Fluid/Blood Leak; Insufficient Device Problem Information
IT WAS REPORTED THAT THE TRIFUSE EXTENSION LEAKED WHEN ATTACHED TO A PRIMARY SET AND WHEN MATED TO A SYRINGE.THE EVENT OCCURRED IN THE ICU . ALTHOUGH REQUESTED THERE WAS NO ADDITIONAL EVENT DETAILS OR PATIENT IMPACT PROVIDED AT THIS TIME. THE CUSTOMER STATED THE LEAKS OCCURRED WHEN REMOVING THE EXTENSION SET FROM THE PACKAGE AND TESTING THE SET WITH A SYRINGE. A VIDEO ATTACHED TO FILE OF PRODUCT FAILURE LEAKS WHEN USING SYRINGE AND SLID CLAMP IS CLAMPED.
Patient problems: No Information
MAUDE report 9845941 ↗MalfunctionDec 6, 2019Fluid/Blood Leak; Insufficient Device Problem Information; Fluid/Blood Leak; Insufficient Device Problem Information
IT WAS REPORTED THAT THE TRIFUSE EXTENSION LEAKED WHEN ATTACHED TO A PRIMARY SET AND WHEN MATED TO A SYRINGE.THE EVENT OCCURRED IN THE ICU. THE CUSTOMER STATED THE LEAKS OCCURRED WHEN REMOVING THE EXTENSION SET FROM THE PACKAGE AND TESTING THE SET WITH A SYRINGE. ALTHOUGH REQUESTED THERE WAS NO ADDITIONAL EVENT DETAILS OR PATIENT IMPACT PROVIDED AT THIS TIME. A VIDEO ATTACHED TO FILE OF PRODUCT FAILURE LEAKS WHEN USING SYRINGE AND SLID CLAMP IS CLAMPED .
Patient problems: No Information
MAUDE report 9434543 ↗MalfunctionNov 13, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE IV FLUID WAS LEAKING OUT AT JUNCTION OF THE TRIFUSE EXTENSION SET. THE EVENT OCCURRED IN THE OPERATING ROOM (OR) OVER THE PAST COUPLE OF MONTHS. THERE WAS NO PATIENT HARM AND THE EVENT DID NOT CAUSE DELAY IN PATIENT THERAPY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9315681 ↗MalfunctionNov 13, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE IV FLUID WAS LEAKING OUT AT JUNCTION OF THE TRIFUSE EXTENSION SET. THE EVENT OCCURRED IN THE OPERATING ROOM (OR) OVER THE PAST COUPLE OF MONTHS. THERE WAS NO PATIENT HARM AND THE EVENT DID NOT CAUSE DELAY IN PATIENT THERAPY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9315679 ↗MalfunctionNov 13, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE IV FLUID WAS LEAKING OUT AT JUNCTION OF THE TRIFUSE EXTENSION SET. THE EVENT OCCURRED IN THE OPERATING ROOM (OR) OVER THE PAST COUPLE OF MONTHS. THERE WAS NO PATIENT HARM AND THE EVENT DID NOT CAUSE DELAY IN PATIENT THERAPY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9315669 ↗MalfunctionNov 13, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE IV FLUID WAS LEAKING OUT AT JUNCTION OF THE TRIFUSE EXTENSION SET. THE EVENT OCCURRED IN THE OPERATING ROOM (OR) OVER THE PAST COUPLE OF MONTHS. THERE WAS NO PATIENT HARM AND THE EVENT DID NOT CAUSE DELAY IN PATIENT THERAPY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9315612 ↗MalfunctionNov 13, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE IV FLUID WAS LEAKING OUT AT THE JUNCTION OF THE TRI-FUSE EXTENSION SET. THE EVENT OCCURRED IN THE OPERATING ROOM (OR). IT WAS CONFIRMED THAT THERE WAS NO PATIENT HARM AND THE EVENT DID NOT CAUSE ANY DELAY IN PATIENT THERAPY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9315053 ↗MalfunctionAug 15, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE NURSES HAVE STATED THAT THERE HAVE BEEN FREQUENT EVENTS IN WHICH THE TRIFUSE TUBING SETS WERE FOUND TO LEAK DURING PATIENT USE, BOTH IN THE PAST AND CURRENTLY, HOWEVER, THE STAFF HAVE NOT APPROPRIATELY REPORTED IT OR ADDRESSED THE ISSUE.
Patient problems: No Information
MAUDE report 8898817 ↗MalfunctionAug 1, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE PATIENT WAS IN DIABETIC KETOACIDOSIS (DKA) RECEIVING A DKA PROTOCOL INFUSION OF DKA FLUIDS AND INSULIN WHEN THE TRIFUSE TUBING SET LEAKED AT THE JUNCTION OF THE 3 ARMS.
Patient problems: No Information
MAUDE report 8851963 ↗MalfunctionJul 29, 2019Insufficient Device Problem Information
THE SET WAS RECEIVED AS AN UNEXPECTED RETURN WITH AN UNKNOWN ISSUE. ALTHOUGH THE CUSTOMER STATED ; "WE HAVE SAMPLES TO SEND THAT ARE LEAKING FROM A PREVIOUS COMPLAINTS IT IS UNKNOWN WHAT THE PRODUCT FAILURE IS ON THE UNEXPECTED SET.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8836544 ↗MalfunctionJul 29, 2019Insufficient Device Problem Information
THE SET WAS RECEIVED AS AN UNEXPECTED RETURN WITH AN UNKNOWN ISSUE. ALTHOUGH THE CUSTOMER STATED; "WE HAVE SAMPLES TO SEND THAT ARE LEAKING FROM A PREVIOUS COMPLAINTS IT IS UNKNOWN WHAT THE PRODUCT FAILURE IS ON THE UNEXPECTED SET.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8836540 ↗MalfunctionJul 25, 2019Leak/Splash
THE SET WAS RECEIVED AS AN UNEXPECTED RETURN WITH AN UNKNOWN ISSUE. ALTHOUGH THE CUSTOMER STATED: "WE HAVE SAMPLES TO SEND THAT ARE LEAKING FROM A PREVIOUS COMPLAINTS IT IS UNKNOWN WHAT THE PRODUCT FAILURE IS ON THE UNEXPECTED SET.''
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8825794 ↗MalfunctionJul 24, 2019Fluid/Blood Leak; Insufficient Device Problem Information; Fluid/Blood Leak; Insufficient Device Problem Information
A NOTE AND PHOTO RECEIVED STATED :LEAKING WHEN ALL THE LINES MET TOGETHER". PHOTO OF THE EXTENSION SET WITH WHITE SUBSTANCE. ALTHOUGH REQUESTED, NO FURTHER DETAILS WERE PROVIDED BY THE CUSTOMER FOR THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8823956 ↗MalfunctionMay 9, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER PROVIDED A PHOTO WITH NOTE ATTACHED TO A TRIFUSE EXTENSION SET THAT STATED: "FAULTY 3 WAY LEAKING FROM UNDER PINK TAPE." AN EVENT DATE OF (B)(6) AND BED 1 WAS ALSO DOCUMENTED ON THE NOTE. ALTHOUGH REQUESTED THE CUSTOMER DID NOT INDICATE ANY PATIENT HARM OR MEDICAL INTERVENTIONS RENDERED. THE EVENT OCCURRED IN THE ICU.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8595771 ↗MalfunctionApr 24, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE SET WAS RECEIVED AS AN UNEXPECTED RETURN WITH A CHANGE DUE DATE STICKER ATTACHED TO TRIFUSE EXTENSION SET THAT STATED; " LEAKING." ALTHOUGH REQUESTED, NO FURTHER DETAILS WERE PROVIDED BY THE CUSTOMER FOR THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8545786 ↗MalfunctionApr 19, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE SET WAS RECEIVED AS AN UNEXPECTED RETURN WITH A REPORT THAT THE TRIFUSE SET LEAKED . A NOTE ATTACHED TO THE SET STATED;" 3 WAY LEAKING".ALTHOUGH REQUESTED, NO FURTHER DETAILS WERE PROVIDED BY THE CUSTOMER FOR THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8533205 ↗MalfunctionApr 19, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE SET WAS RECEIVED AS AN UNEXPECTED RETURN WITH A REPORT THAT THE SET LEAKED LIPIDS. A NOTE RECEIVED WITH THE PRODUCT THAT STATED:" LEAKING WHEN ALL THE LINES MET TOGETHER".ALTHOUGH REQUESTED, NO FURTHER DETAILS WERE PROVIDED BY THE CUSTOMER FOR THIS EVENT. UPON INVESTIGATION OF THE SET RECEIVED A LEAK WAS NOTED HOWEVER THE SET DID NOT A CONTAIN A WHITE SUBSTANCE INSIDE OF THE SET.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8532489 ↗MalfunctionApr 4, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT IN THE ANESTHESIA DEPARTMENT, A TRI-FUSE SET LEAK WHEN USED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION HAS BEEN RECEIVED.
Patient problems: No Information
MAUDE report 8482859 ↗MalfunctionApr 3, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT IN THE ANESTHESIA DEPARTMENT, A TRI-FUSE SET LEAK WHEN USED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION HAS BEEN RECEIVED.
Patient problems: No Information
MAUDE report 8480617 ↗MalfunctionApr 3, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT IN THE ANESTHESIA DEPARTMENT, A TRI-FUSE SET LEAK WHEN USED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION HAS BEEN RECEIVED.
Patient problems: No Information
MAUDE report 8480615 ↗MalfunctionApr 3, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT IN THE ANESTHESIA DEPARTMENT, A TRI-FUSE SET LEAK WHEN USED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION HAS BEEN RECEIVED.
Patient problems: No Information
MAUDE report 8480562 ↗MalfunctionApr 3, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT IN THE ANESTHESIA DEPARTMENT, A TRI-FUSE SET LEAK WHEN USED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION HAS BEEN RECEIVED.
Patient problems: No Information
MAUDE report 8480408 ↗
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.