MaxGuard MFS106Recalls & reported problems
BD Switzerland Sàrl · Flow Controller Extension Set, with Needless Y-Site, 58 cm (23 in) · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403236358), received between May 14, 2019 and Mar 3, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (1 report).
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
- Aug 1, 2022Open, Classified
Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker.
Z-1754-2022 · Root cause: Error in labeling · FDA record ↗
Most reported problems
Device problems
- Deformation Due to Compressive Stress1
- Excess Flow or Over-Infusion1
- Improper Flow or Infusion1
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.
MalfunctionMar 3, 2023Deformation Due to Compressive Stress; Improper Flow or Infusion; Deformation Due to Compressive Stress; Improper Flow or Infusion
IT WAS REPORTED THAT THE BD MAXGUARD¿ FLOW CONTROLLER EXTENSION SET WITH NEEDLELESS Y-SITE(S) TUBING HAD A KINK IN IT THAT CAUSED FLOW ISSUES DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "KINKED TUBING ON #MFS106. THE KINK IN THE TUBING DOESN¿T LET THE FLUIDS FLOW CORRECTLY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16482553 ↗MalfunctionMay 14, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
IT WAS REPORTED THAT THE EXTENSION SET USED DURING AN UNSPECIFIED INFUSION INFUSED FASTER THAN EXPECTED. THE FACILITY PERFORMED AN INTERNAL TEST USING A SALINE 1 LITER PROGRAMMED TO INFUSE AT 250 ML/HR. OVER 4 HRS. HOWEVER INFUSED UNDER 3 HRS. THE CUSTOMER REPORTED NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8609263 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.