Jelco 308600Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of Jelco (101)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10351688071316), received between May 14, 2018 and May 12, 2025 — classified as 2 injuries, 3 malfunctions.
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. 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
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Dull, Blunt1
- Physical Resistance/Sticking1
- Retraction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Pain1
- Reaction, Injection Site1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 12, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT BEFORE INITIATING THE IV PROCEDURE ON THE PATIENT, THE INDIVIDUAL ENCOUNTERED DIFFICULTY REMOVING THE NEEDLE CAP, AS IT SEEMED STUCK. THEY APPLIED ADDITIONAL PRESSURE TO DETACH IT, AND WHEN IT FINALLY CAME LOOSE, IT RECOILED, PUNCTURING THEIR GLOVE AND CAUSING AN ACCIDENTAL NEEDLESTICK. THE NEEDLE WAS IMMEDIATELY DISPOSED OF IN THE SHARP'S CONTAINER. NO BLOOD FROM THE INDIVIDUAL CAME INTO CONTACT WITH THE PATIENT. FOLLOWING THE INCIDENT, THE GLOVES WERE REMOVED, THE WOUND WAS RINSED THOROUGHLY, AND A BANDAGE WAS APPLIED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22002705 ↗MalfunctionJan 9, 2025Break; Break
IT WAS REPORTED THAT ¿CATHETER FOUND OUT OF THE BANDAGE, DISCOVERED SECTIONED CATHETER. SEARCHING FOR CATHETER END WAS NOT SUCCESSFUL. DOCTOR CONTACTED IMMEDIATELY. CATHETER TIP FOUND IN VEIN UNDER ULTRASOUND. THERE WAS PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21118087 ↗MalfunctionMay 21, 2024Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE GRIPPER PADS WERE PULLED BACK AND THE DEVICE WAS STUCK AND WON'T ALLOW THE NEEDLE RETRACTION INTO THE NEEDLE GUARD. IN THIS INSTANCE WHEN THE CLINICIAN PULLED THE NEEDLE GUARD OUT OF THE HUB, A MAJORITY OF NEEDLE WAS EXPOSED. AT THAT POINT IT WAS IMPOSSIBLE TO PULL THE NEEDLE INTO THE NEEDLE GUARD. THE ISSUE HAPPENED DURING USE WITH A PATIENT. THERE WAS PATIENT INVOLVEMENT AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19361818 ↗InjuryMar 4, 2022Dull, Blunt; Dull, Blunt
IT WAS REPORTED THAT THE STAFF HAVE COMPLAINED THAT THE SUBSTITUTION WITH WING IS NOT AS GOOD AS THE PREVIOUS CATHETER. THE NEEDLE IS DULL IN COMPARISON AND PATIENTS ARE COMPLAINING OF PAIN ON INSERTION.
Patient problems: Pain
MAUDE report 13667502 ↗InjuryMay 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A JELCO® PROTECTIV® SAFETY I.V. CATHETER HAS BEEN SET ON THE (B)(6) 2017 ON A PATIENT BY A NURSE. ON THE MORNING OF THE (B)(6) 2017, A LYMPHANGITIS APPEARED IN PATIENT'S ARM BEFORE THE CORONOGRAPHY TEST.
Patient problems: Reaction, Injection Site
MAUDE report 7511358 ↗
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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 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.
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