Lifeshield 1140228Recalls & reported problems
ICU Medical, Inc. · LIFESHIELD, Microbore Extension Set - 5 Inch, Prepierced T-Site with Spin Collar · Class 2
All models of Lifeshield (34)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887787005124), received between Jun 14, 2024 and Jun 14, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 14, 2024Material Separation; Material Separation
THE EVENT INVOLVED A MICR0BORE EXT SET 5IN PP T-SITE NDEHP WHERE THE CUSTOMER STATED THAT A PATIENT WAS IN BED WHEN A CAREGIVER WENT INTO THE ROOM, SHE THOUGHT THAT THE PATIENT HAD COMPLETELY PULLED THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE. THE NURSE WAS NOTIFIED AND UPON INSPECTION, THE PICC WAS STILL IN PLACE, BUT THE T-CONNECTOR HAD COME APART WHERE THE TUBING ATTACHES TO THE GREEN HUB. THE NURSE PRACTITIONER WAS ABLE TO SAVE THE PICC BUT NEW TUBING WAS NEEDED. THE OPEN AREA, WHERE THE TUBING DISCONNECTED, EXPOSED THE INFANT TO POTENTIAL INFECTION. THIS IS THE SECOND ONE THEY HAVE DONE THIS BUT DO NOT HAVE LOT NUMBERS. THE PATIENT WAS FEMALE, BLACK, OR AFRICAN AMERICAN. THE EVENT OCCURRED IN THE HOSPITAL IN NEONATAL INTENSIVE CARE UNIT (NICU). THE ORIGINAL INTENDED PROCEDURE WAS CONNECTOR FOR PERIPHERALLY INSERTED CENTRAL CATHETER AND TUBING. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT OR STAFF HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19536149 ↗
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page