Lifeshield 1141505Recalls & reported problems
ICU Medical, Inc. · LIFESHIELD, Extension Set - 15 Inch, 1.2 Micron Filter, Prepierced Y-Site, Secure Lock · Class 2
- 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 10887787005131), received between Aug 9, 2022 and Aug 9, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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
- Device Contamination with Chemical or Other Material1
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.
MalfunctionAug 9, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
THE EVENT OCCURRED IN A HOSPITAL PATIENT ROOM AND INVOLVED A LIFESHIELD¿ EXTENSION SET - 15 INCH 1.2 MICRON FILTER, PREPIERCED Y-SITE, NON-DEHP. A USER FACILITY MANDATORY MEDWATCH (#(B)(4)) WAS RECEIVED THAT STATED, ¿THE NURSE WENT TO DISCARD THE OLD TPN (TOTAL PARENTERAL NUTRITION), TUBING, AND EXTENSION SET TO REPLACE IT WITH NEW TPN, TUBING, AND EXTENSION SET. ON AN ATTEMPT TO REMOVE THE EXTENSION SET FROM THE CVC LUMEN, THE SECURE LOCK MALE ADAPTER WAS UNSCREWED UPON PULLING BACK IT WOULD NOT DISLODGE FROM THE CVC LUMEN. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE LINE WITH NO SUCCESS. ON THE LAST ATTEMPT, THE TIP OF THE ADAPTOR BROKE OFF IN THE PURPLE LUMEN; DISCARDING OLD TPN, TUBING AND EXTENSION SET TO REPLACE WITH NEW WAS THE ORIGINAL INTENDED PROCEDURE. DEVICES FAILED WAS THE PROBLEM OF THE USER HAVE. OTHER THERAPIES USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT: TOTAL PARENTERAL NUTRITION (TPN) BECOMES STICKY WHEN IT DRIES.¿ IT WAS LATER REPORTED BY THE CUSTOMER THAT THE STICKY TPN DRIED AROUND THE SECURE LOCK MALE ADAPTOR OF THE EXTENSION TUBING, MAKING IT DIFFICULT TO REMOVE FROM THE CVC LUMEN. ALTHOUGH THERE WAS PATIENT IN
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15190530 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.