Jelco 982106Recalls & reported problems
Icu Medical, Inc. · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20351688060508), received between May 23, 2016 and Jan 5, 2022 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Disconnection” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Disconnection3
- Protective Measures Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 5, 2022Disconnection; Disconnection
IT WAS REPORTED THAT DURING BLOOD SAMPLING, THE HOLDER DISCONNECTED FROM MICRO-INFUSOR LEADING TO SLIGHT LOSS OF BLOOD FROM PATIENT (UNDER ANTICOAGULANT TREATMENT). NO OTHER CLINICAL CONSEQUENCE OBSERVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13170025 ↗MalfunctionJan 4, 2022Disconnection; Disconnection
IT WAS REPORTED THAT DURING BLOOD SAMPLING, THE HOLDER DISCONNECTED FROM MICRO-INFUSOR LEADING TO SLIGHT LOSS OF BLOOD FROM PATIENT (UNDER ANTICOAGULANT TREATMENT). NO OTHER CLINICAL CONSEQUENCE OBSERVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13153752 ↗MalfunctionJan 4, 2022Disconnection; Disconnection
IT WAS REPORTED THAT DURING BLOOD SAMPLING, THE HOLDER DISCONNECTED FROM MICRO-INFUSOR LEADING TO SLIGHT LOSS OF BLOOD FROM PATIENT (UNDER ANTICOAGULANT TREATMENT). NO OTHER CLINICAL CONSEQUENCE OBSERVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13153433 ↗MalfunctionMay 23, 2016Protective Measures Problem; Protective Measures Problem
USER FACILITY REPORTED THE DEVICE WAS IN USE FOR PATIENT BLOOD DRAW. ACCORDING TO REPORTER, THE DEVICE NEEDLE PROTECTOR BROKE AND THE USED NEEDLE WAS EXPOSED. REPORTER STATED THAT BLOOD LEAKAGE OCCURRED BUT USERS DID NOT SUSTAIN ANY DIRECT CONTACT WITH THE BLOOD. NO ADVERSE EFFECTS TO PATIENT OR USER REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5673862 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.