MaxGuard ME1110Recalls & reported problems
BD Switzerland Sàrl · Extension Set, (minibore) 91 cm (36 in) · Class 2
All models of MaxGuard (49)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885403236044), received between Apr 9, 2020 and Jan 5, 2022 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
Device problems
- Break3
- Component Missing1
- Device Contamination with Chemical or Other Material1
- Leak/Splash1
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
- No Information1
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 5, 2022Break
PLASTIC THREADED CAP BROKE OFF ON EXTENSION SET. SECOND TIME IN ONE WEEK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13168200 ↗MalfunctionOct 30, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE 36 IN NON-DEHP MINIBORE EXTENSION SET CRACKED AT THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SEVERAL STAFF MEMBERS ARE REPORTING THAT THE EXTENSION SET IS CRACKING AT THE HUB. THE LATEST ISSUE WAS WITH LOT # 20045106."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10766677 ↗MalfunctionOct 27, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT 36 IN NON-DEHP MINIBORE EXTENSION SET HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: BATCH NO: IT WAS REPORTED THAT THERE WAS A FOREIGN CONTAMINATION OF A HAIR INVOLVING THE EXTENSION SET.
Patient problems: No Patient Involvement
MAUDE report 10744509 ↗MalfunctionMay 11, 2020Component Missing; Component Missing
UNEXPECTED RETURN - IT WAS REPORTED FROM THE NICU THAT THE IV TUBING WAS MISSING THE MALE LUER. PER CUSTOMER, NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Information
MAUDE report 10044857 ↗MalfunctionMay 10, 2020Break; Break
RECEIVED A COPY OF THE CUSTOMER'S MEDSUN REPORT FROM FDA WHICH STATES, ¿BLOOD TRANSFUSION COMPLETED, LINE DISCONNECTED TO ATTACH AND FLUSH. HUB ON BLOOD TUBING BROKE INSIDE OF PIV LUER LOCK. LUER LOCK (Q SITE CHANGED) AND LINE WAS FLUSHED." IT WAS REPORTED FROM THE NICU THAT AFTER A BLOOD TRANSFUSION WAS COMPLETED, THE LINE WAS DISCONNECTED TO ATTACH AND FLUSH. THE HUB ON THE BLOOD TUBING WAS BROKEN INSIDE OF THE PIV LUER LOCK, THE LUER LOCK (Q SITE) WAS CHANGE AND THE LINE WAS FLUSHED. THERE WAS NO PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10041621 ↗MalfunctionApr 9, 2020Break
BLOOD TRANSFUSION COMPLETED, LINE DISCONNECTED TO ATTACH AND FLUSH. HUB ON BLOOD TUBING BROKE INSIDE OF PIV LUER LOCK. LUER LOCK (Q SITE CHANGED) AND LINE WAS FLUSHED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9943273 ↗
Other Set, administration, intravascular devices
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- 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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