Lifeshield 1205328Recalls & reported problems
ICU Medical, Inc. · LIFESHIELD, Microbore Extension Set - 5 Inch, CLAVE Connector, Prepierced T-Site with Spin Collar · 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 10887787005209), received between May 14, 2019 and Aug 13, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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
- Detachment of Device or Device Component1
- Fluid/Blood Leak1
Patient problems
- Blood Loss1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 13, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE EVENT INVOLVED A REPORT STATING THAT THE EXTENSION TUBING HAS DISCONNECTED FROM THE MICROBORE T CONNECTOR PART; IT HAS SEPARATED FROM INSIDE THE CONNECTOR. IT WAS NOT PULLED ON, NOT DAMAGED, IT JUST SUDDENLY DISCONNECTED AND WAS ATTACHED TO A CENTRAL LINE. THE BABY STARTED BLEEDING OUT OF THE T- CONNECTOR. THE EVENT WAS NOTICED WHEN THE NURSE DID THE ROUNDS IN NICU. THERE WAS PATIENT INVOLVEMENT, AND "SOME BLOOD LOSS BUT NOTHING PERMANENT".
Patient problems: Blood Loss
MAUDE report 8887812 ↗MalfunctionMay 14, 2019Detachment of Device or Device Component
RNS WERE ATTEMPTING TO START AN IV ON A PATIENT. AFTER GETTING IV SITE, RNS ATTEMPTED TO CONNECT EXTENSION SET AND UPON SECURING DEVICE TO HUB OF IV CATHETER THE SPIN COLLAR DEVICE DETACHED FROM THE DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8607418 ↗
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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 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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