Jelco 402705Recalls & reported problems
Icu Medical, Inc. · Class 2
- 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 00351688070909), received between Oct 10, 2017 and Oct 10, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
- 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.
InjuryOct 10, 2017Break; Protective Measures Problem; Break; Protective Measures Problem
IT WAS REPORTED THAT THE SAFETY DEVICE OF A JELCO® HYPODERMIC NEEDLE-PRO® EDGE¿ BROKE, AND THE CLINICIAN RECEIVED A DIRTY NEEDLE STICK. THE DEVICE HAD BEEN USED FOR SUBCUTANEOUS INFUSION OF HEPARIN. AFTER THE CLINICIAN ENGAGED THE SAFETY DEVICE, THE SAFETY DEVICE BROKE, AND THE TOP OF THE NEEDLE CAME OFF OF THE SYRINGE. THE CLINICIAN WAS STUCK BY THE NEEDLE ON THE LEFT INDEX FINGER AS THIS OCCURRED. FACILITY NEEDLE STICK EMPLOYEE HEALTH PROTOCOL WAS FOLLOWED. NO PERMANENT INJURY WAS REPORTED.
Patient problems: Needle Stick/Puncture
MAUDE report 6937532 ↗
Other Needle, hypodermic, single lumen devices
- BD Nano 2nd Gen 320550Becton Dickinson Pen Limited · Needle, hypodermic, single lumen2,044 reports
- BD SafetyGlide 305916Becton, Dickinson And Company · Needle, hypodermic, single lumen1,767 reports
- BD Nano Ultra-Fine 320122Becton Dickinson Pen Limited · Needle, hypodermic, single lumen601 reports
- N/A 305106Becton, Dickinson And Company · Needle, hypodermic, single lumen1 recall467 reports
- N/A 305110Becton, Dickinson And Company · Needle, hypodermic, single lumen418 reports
- BD Safe-Clip 328235Becton, Dickinson and Company Inc · Needle, hypodermic, single lumen268 reports
- BD Ultra-Fine 320109Becton Dickinson Pen Limited · Needle, hypodermic, single lumen229 reports
- BD AutoShield Duo 329515Becton, Dickinson And Company · Needle, hypodermic, single lumen208 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.