Jelco 401810Recalls & reported problems
Icu Medical, Inc. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00351688069781), received between Feb 8, 2017 and Feb 8, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Bent” (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
- Bent1
- Protective Measures Problem1
Patient problems
- Needle Stick/Puncture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 8, 2017Bent; Protective Measures Problem; Bent; Protective Measures Problem
IT WAS REPORTED THAT A JELCO® HYPODERMIC NEEDLE-PRO® EDGE¿ SAFETY DEVICE WAS IN USE WITH A PATIENT WHEN THE USER ATTEMPTED TO ACTIVATE THE SAFETY LOCK ON THE NEEDLE, WHICH CAUSED THE NEEDLE TO POP OFF AND CAUSED A NEEDLESTICK TO THE USER. IT WAS NOTED THAT AS THE DEVICE WAS PRESSED AGAINST A HARD SURFACE, THE NEEDLE BENT. DUE TO THE NEEDLESTICK, THE USER FOLLOWED A BLOODBORNE PATHOGEN PROTOCOL. NO PATIENT INJURY WAS REPORTED. NO MEDICAL TREATMENT WAS CONDUCTED.
Patient problems: Needle Stick/Puncture
MAUDE report 6312306 ↗
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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 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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