MaxGuard ME2059Recalls & reported problems
BD Switzerland Sàrl · Extension Set, (microbore) 182 cm (72 in) · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403236273), received between Jan 15, 2021 and Jul 22, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Complete Blockage” (2 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.
Most reported problems
Device problems
- Complete Blockage2
- Restricted Flow rate2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 22, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate
IT WAS REPORTED THAT 3 72-IN NON-DEHP MICROBOREE EXT SETS WERE BLOCKED/OCCLUDED, AND MEDICINE HAD TO BE MANUALLY PUSHED THROUGH THE SYRINGE PUMP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAVE SOME SYRINGE PUMP TUBING (BD MAXGUARD EXTENSION SET REFME2059 WITH AN ATTACHED NEXUS TKO NEEDLELESS CONNECTOR) THAT WOULDN¿T INFUSE LAST NIGHT WHEN THE NURSE USED AN ALARIS SYRINGE PUMP. SHE WAS ABLE TO MANUALLY PUSH THE MEDICATION THROUGH THE SYRINGE PUMP TUBING, BUT THE PUMP WOULD NOT DELIVER THE MEDICATION."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12208162 ↗MalfunctionJan 15, 2021Complete Blockage; Restricted Flow rate
IT WAS REPORTED THAT 5 72-IN NON-DEHP MICROBOREE EXT SETS WERE CLOGGED/BLOCKED/OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RN USED 5 DIFFERENT SETS OF SYRINGE TUBING BD MAXGUARD EXTESION SET , REF#ME2059, LOT #20047165 VERY DIFFICULT TO PRIME WITH SALINE. PUMP BEEPED OCCLUSION THE WHOLE TIME WHILE TRYING TO INFUSE BENEDRYL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11175818 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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