MaxGuard ME2050Recalls & reported problems
BD Switzerland Sàrl · Extension Set (minibore) 152 cm (60 in) · Class 2
All models of MaxGuard (49)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10885403236266), received between Nov 11, 2019 and Mar 23, 2020 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Break” (10 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 18, 2026.
Most reported problems
Device problems
- Break10
Patient problems
- No Patient Involvement7
- No Information4
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 23, 2020Break; Break
IT WAS REPORTED THAT THE PLASTIC COLLAR IS BROKEN WHICH OCCURS UPON CONNECTION OR DISCONNECTION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9865156 ↗MalfunctionMar 23, 2020Break; Break
IT WAS REPORTED THAT THE PLASTIC COLLAR IS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9865153 ↗MalfunctionMar 23, 2020Break; Break
IT WAS REPORTED THAT THE PLASTIC COLLAR IS BROKEN WHICH OCCURS UPON CONNECTION OR DISCONNECTION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9865151 ↗MalfunctionMar 23, 2020Break; Break
IT WAS REPORTED THAT THE PLASTIC COLLAR IS BROKEN WHICH OCCURS UPON CONNECTION OR DISCONNECTION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9865093 ↗MalfunctionMar 23, 2020Break; Break
IT WAS REPORTED THAT THE PLASTIC COLLAR IS BROKEN WHICH OCCURS UPON CONNECTION OR DISCONNECTION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9865092 ↗MalfunctionMar 23, 2020Break; Break
IT WAS REPORTED THAT THE PLASTIC COLLAR IS BROKEN WHICH OCCURS UPON CONNECTION OR DISCONNECTION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9865035 ↗MalfunctionMar 23, 2020Break; Break
IT WAS REPORTED THAT THE PLASTIC COLLAR IS BROKEN WHICH OCCURS UPON CONNECTION OR DISCONNECTION.
Patient problems: No Information; No Patient Involvement
MAUDE report 9865034 ↗MalfunctionNov 23, 2019Break; Break
IT WAS REPORTED THAT THE SPIN COLLAR SHATTERED. THE CUSTOMER STATED; " I HAVE NO OTHER INFORMATION AS REQUESTED". ALTHOUGH PATIENT IMPACT WAS REQUESTED IT WAS NOT PROVIDED. A NOTE ATTACHED TO PRODUCT THAT STATED : "MICROBORE TUBING AT BEDSIDE TO BE USED FOR INTERMITTENT MEDICATION ADMINISTRATION. HAD A CUROS CAP STERILE END COVER ON ONE END , SALINE FLUSH ON THE OTHER END. NURSE WENT TO PULL OFF THE CUROS CAP AND PLASTIC HUB SHATTERED INTO PARTS IN HER HAND. BELIEVE TO BE ME2050 CAREFUSION MAX GUARD SET. "EVENT DATE (B)(6) 2019"
Patient problems: No Information
MAUDE report 9366803 ↗MalfunctionNov 20, 2019Break; Break
IT WAS REPORTED THAT THE MALE-END CONNECTOR BROKE OFF INSIDE THE SMARTSIDE END CAP. THE CUSTOMER STATED; " I HAVE NO OTHER INFORMATION AS REQUESTED." ALTHOUGH INQUIRY TO PATIENT IMPACT WAS REQUESTED, BUT IT WAS NOT PROVIDED. (A NOTE RECEIVED WITH PRODUCT THAT STATED ; "CHECK END CAP WITH PIECE STUCK INSIDE- BROKE END CAP AND BROKEN INTERMITTENT TUBING. WHILE DISCONNECTING THE INT TUBING FROM THE END CAP ON PATIENT PICC LINE, BOTH END CAPS BROKE OFF. THE PATIENT WAS DUE FOR A CAP CHANGE ANYWAY BUT CHANGED THE END CAP".)
Patient problems: No Information
MAUDE report 9349822 ↗MalfunctionNov 11, 2019Break; Break
IT WAS REPORTED THAT THE MALE-END CONNECTOR BROKE OFF INSIDE THE SMARTSIDE END-CAP, OF THE EXTENSION TUBING. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL EVENT DETAILS OR PATIENT INFORMATION PROVIDED.
Patient problems: No Information
MAUDE report 9304541 ↗
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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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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