MaxGuard ME2020Recalls & reported problems
BD Switzerland Sàrl · Extension Set (Microbore) 152 cm (60 in) · Class 2
Quick summary
This BD MaxGuard extension set appears in 92 adverse event reports, with no deaths and no injuries. Reports mostly describe the tubing becoming completely blocked, leaking at the connectors, or breaking, and sometimes failing to flush or prime. Some reports describe a patient being disconnected from fluids while replacement sets were tried. No recalls name this device.
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
- 94
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI 10885403236259), received between Feb 4, 2020 and Sep 24, 2026 — classified as 94 malfunctions.
The most frequently reported specific device problem is “Complete Blockage” (37 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Complete Blockage37
- Leak/Splash23
- Break13
- Defective Component4
- Crack2
- Defective Device2
- Detachment of Device or Device Component2
- Fluid/Blood Leak2
Patient problems
- No Clinical Signs, Symptoms or Conditions79
- Insufficient Information6
- No Consequences Or Impact To Patient6
- Low Blood Pressure/ Hypotension2
- Hypoglycemia1
- No Information1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 94 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Contamination /Decontamination Problem
It was reported that BD alaris extension set had foreign matter The following information was received by the initial reporter with the following VerbatimIt was reported by customer that the Black speck present within the tubing line.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876666 ↗MalfunctionSep 21, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846895 ↗MalfunctionSep 9, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702904 ↗MalfunctionJun 11, 2026Material Twisted/Bent
IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET WAS KINKED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY A CUSTOMER THAT THE SYRINGE TUBING AND LODGED WITHIN THE IV CLAVE. THEY WERE UNABLE TO REMOVE IT, WHICH ULTIMATELY REQUIRED THE ENTIRE CLAVE TO BE CHANGED ON A PEDIATRIC IV. ALSO, THE TUBING IS TIGHTLY COILED WITHIN THE PACKAGING, AND WHEN OPENED QUICKLY, IT TENDS TO BECOME TANGLED AND DIFFICULT TO UNRAVEL. THIS CREATES DELAYS AND FRUSTRATION DURING PATIENT CAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25474088 ↗MalfunctionJun 11, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET HAD CONNECTION ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY A CUSTOMER THAT THE SYRINGE TUBING AND LODGED WITHIN THE IV CLAVE. THEY WERE UNABLE TO REMOVE IT, WHICH ULTIMATELY REQUIRED THE ENTIRE CLAVE TO BE CHANGED ON A PEDIATRIC IV. ALSO, THE TUBING IS TIGHTLY COILED WITHIN THE PACKAGING, AND WHEN OPENED QUICKLY, IT TENDS TO BECOME TANGLED AND DIFFICULT TO UNRAVEL. THIS CREATES DELAYS AND FRUSTRATION DURING PATIENT CARE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25474085 ↗MalfunctionJun 11, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY A CUSTOMER THAT THE SYRINGE TUBING AND LODGED WITHIN THE IV CLAVE. THEY WERE UNABLE TO REMOVE IT, WHICH ULTIMATELY REQUIRED THE ENTIRE CLAVE TO BE CHANGED ON A PEDIATRIC IV. ALSO, THE TUBING IS TIGHTLY COILED WITHIN THE PACKAGING, AND WHEN OPENED QUICKLY, IT TENDS TO BECOME TANGLED AND DIFFICULT TO UNRAVEL. THIS CREATES DELAYS AND FRUSTRATION DURING PATIENT CARE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25473298 ↗MalfunctionMar 23, 2026Leak/Splash
IT WAS REPORTED "MEDICATION WAS LEAKING FROM THE MEDICATION LINE, BETWEEN THE LUER LOCK AND THE LINE". NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24662046 ↗MalfunctionMar 17, 2026
OPENED NEW BD MICROBORE TUBING AND UNABLE TO FLUSH IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24616290 ↗MalfunctionFeb 14, 2026Complete Blockage
PATIENT BECAME DISCONNECTED FROM FLUIDS. UPON CHANGING TUBING AND RECONNECTING PATIENT, THE BD MAXGUARD EXTENSION SET (MICROBORE) WOULD NOT FLUSH TO PRIME THE LINE. TWO MORE EXTENSION SETS WERE OBTAINED AND WOULD NOT FLUSH TO PRIME THE LINE. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24341239 ↗MalfunctionFeb 14, 2026Complete Blockage
PATIENT BECAME DISCONNECTED FROM FLUIDS. UPON CHANGING TUBING AND RECONNECTING PATIENT, THE BD MAXGUARD EXTENSION SET (MICROBORE) WOULD NOT FLUSH TO PRIME THE LINE. TWO MORE EXTENSION SETS WERE OBTAINED AND WOULD NOT FLUSH TO PRIME THE LINE. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24341238 ↗MalfunctionFeb 2, 2026Backflow; Complete Blockage
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24242230 ↗MalfunctionJan 28, 2026Leak/Splash
IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT WOULD NOT PRIME AND/OR WAS LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24202718 ↗MalfunctionJan 28, 2026Leak/Splash
IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT WOULD NOT PRIME AND/OR WAS LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24202717 ↗MalfunctionJan 22, 2026Leak/Splash
IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT WOULD NOT PRIME AND/OR WAS LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24151562 ↗MalfunctionJan 22, 2026Leak/Splash
IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT WOULD NOT PRIME AND/OR WAS LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24149792 ↗MalfunctionJan 21, 2026Leak/Splash
IT WAS REPORTED THAT THE BD EXTENSION SET (MICROBORE) 152 CM (60 IN) HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RECEIVED AN EMAIL THAT ME2020 WAS LEAKING. IT SAID THERE HAVE BEEN MULTIPLE ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24135407 ↗MalfunctionJan 21, 2026Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24135380 ↗MalfunctionJan 13, 2026No Flow
IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY THE CUSTOMER THAT THE JLOOP HAD FLUID LEAKING AT THE CAP. UNABLE TO DETERMINE IF PROBLEM IS OCCURRING DUE TO THE TRIFUSE OR JLOOP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24053748 ↗MalfunctionJan 13, 2026No Flow
IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT THE JLOOP HAD FLUID LEAKING AT THE CAP. UNABLE TO DETERMINE IF PROBLEM IS OCCURRING DUE TO THE TRIFUSE OR JLOOP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24053746 ↗MalfunctionDec 30, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED THAT THE BD MAXGUARD EXTENSION SET HAD KINKED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STERILE COMPOUNDING TECHNICIANS HAVE IDENTIFIED THE NICU TUBING HAS BEEN MORE TANGLED WITHIN IT'S MANUFACTURE PACKAGING. THIS IS CAUSING MORE MANIPULATION AND BUBBLES WITHIN THE TUBING. MODEL #: ME2020. LOT #: 25075472.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23928550 ↗MalfunctionDec 22, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT THE BD EXTENSION SET (MICROBORE) 152 CM (60 IN) HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE NOW HAD 6 EXTENSION SET IV TUBING SETS THAT WE CANNOT FLUSH OR PRIME. WE HAVE KEPT SEVERAL PACKAGES. THEY ARE ALL PART OF THE SAME LOT # 25095198. INCIDENTS RELATED TO FLUSHING AN EXTENSION SET, ME2020, EXTENSION SET MICROBORE SLIDE CLAMP(S) SPIN MALE LUER LOCK. NOT MADE WITH DEHP. L: 60 IN L: 152 CM PV: 0.3 ML CONTENT STERILE - ME2020 / BD WE HAVE BEEN FINDING THE TUBING OVER THE COURSE 2 WEEKS 11-03-2025 TO 11-17-2025. TUBING WOULD NOT FLUSH. WE DID HAVE TO REQUEST AND ADDITIONAL DOSE OF A MEDICATION TRYING TO TROUBLE SHOOT THE ISSUE. OTHERWISE WE JUST REPLACED THE TUBING WITH ANOTHER EXTENSION SET. I KEPT 4 OF THE DEFECTIVE SAMPLES IF YOU WOULD LIKE ME TO SEND THEM IN FOR TESTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23863645 ↗MalfunctionDec 16, 2025Complete Blockage; Leak/Splash; Complete Blockage; Leak/Splash
IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT THEY HAVE HAD MULTIPLE BD MAX GUARD MICROBORE EXTENSION SET REF ME2020, LOT: 25095198, THAT HAVE NOT BEEN PATENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23824379 ↗MalfunctionDec 16, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET HAD FLOW ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING IT WAS REPORTED BY CUSTOMER THAT THEY HAD 6 EXTENSION SET IV TUBING SETS THAT WE CANNOT FLUSH OR PRIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23822251 ↗MalfunctionDec 9, 2025Complete Blockage; Complete Blockage
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23764507 ↗MalfunctionNov 11, 2025Nonstandard Device; Defective Device; Nonstandard Device; Defective Device
IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT ITEM IS UNABLE TO BE FLUSHED OF MEDICATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23528794 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.