Jelco 308700Recalls & 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
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10351688071323), received between Jul 21, 2017 and Dec 30, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (4 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. 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
- Leak/Splash4
- Protective Measures Problem3
- Component Missing1
- Detachment Of Device Component1
- Device Markings/Labelling Problem1
- Missing Information1
Patient problems
- No Consequences Or Impact To Patient3
- Blood Loss1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 30, 2025Leak/Splash; Leak/Splash
IT WAS STATED IN THE REPORT THAT THE DOCTOR PERFORMED AN INDWELLING NEEDLE PUNCTURE FOR A PATIENT UNDERGOING A PAINLESS OUTPATIENT GASTROINTESTINAL ENDOSCOPY. AFTER SEEING BLOOD RETURN DURING THE PUNCTURE, WHEN THE CATHETER ASSEMBLY WAS ADVANCED INTO THE BLOOD VESSEL, THE NEEDLE SAFETY DEVICE DETACHED. AFTER DETACHMENT, BLOOD FLOWED OUT FROM THE CATHETER ASSEMBLY, CAUSING THE PATIENT TO FEEL DISSATISFIED, LEADING TO BLOOD PRESSURE FLUCTUATIONS AND AFFECTING ANESTHESIA AND THE GASTROINTESTINAL ENDOSCOPY. THERE WAS PATIENT INVOLVEMENT/ NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23924850 ↗MalfunctionNov 6, 2018Component Missing; Device Markings/Labelling Problem; Missing Information; Component Missing; Device Markings/Labelling Problem; Missing Information
INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL JELCO PROTECTIVE SAFETY I.V. CATHETER WAS MISSING FROM THE PEEL PACK AND ALSO HAD A MISSING LABEL PRINT ON THE PACKAGING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8043978 ↗MalfunctionAug 16, 2017Detachment Of Device Component; Detachment Of Device Component
IT WAS REPORTED THAT AN INTRAVASCULAR (IV) CATHETER WAS USED WITH A PATIENT WHEN THE HUB DETACHED FROM THE "ANGIO" CATHETER IMMEDIATELY UPON USE. THE IV WAS STARTED WITH AN "ANGIO" NEEDLE. THE USER WAS ABLE TO OBTAIN BLOOD RETURN AND ADVANCED THE CATHETER UNTIL "IT CLICKED". THE NEEDLE WAS RETRACTED WITHOUT LOOSENING THE CONNECTION OR DETACHING THE "ANGIO" NEEDLE FROM THE HUB. DUE TO THE INCIDENT, BLOOD LOSS OCCURRED AT THE PATIENT'S HAND. THE USER APPLIED DIGITAL PRESSURE TO MINIMIZE BLOOD LOSS. THE USER WAS ABLE TO CONNECT THE IV TUBING TO THE HUB AND TAPED THE TUBING TO THE PATIENT'S HAND. NO MEDICAL INTERVENTION WAS REQUIRED. NO PATIENT OR CLINICIAN INJURY OCCURRED.
Patient problems: Blood Loss
MAUDE report 6797998 ↗MalfunctionJul 21, 2017Leak/Splash; Protective Measures Problem; Leak/Splash; Protective Measures Problem
IT WAS REPORTED THAT THE SAFETY DEVICE OF A JELCO® PROTECTIV® SAFETY I.V. CATHETER SEPARATES FROM THE HUB, CAUSING BLOOD TO FLOW OUT OF THE HUB. NO INJURY TO PATIENT OR CLINICIAN WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6732418 ↗MalfunctionJul 21, 2017Leak/Splash; Protective Measures Problem; Leak/Splash; Protective Measures Problem
IT WAS REPORTED THAT THE SAFETY DEVICE OF A JELCO® PROTECTIV® SAFETY I.V. CATHETER SEPARATES FROM THE HUB, CAUSING BLOOD TO FLOW OUT OF THE HUB. NO INJURY TO PATIENT OR CLINICIAN WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6732414 ↗MalfunctionJul 21, 2017Leak/Splash; Protective Measures Problem; Leak/Splash; Protective Measures Problem
IT WAS REPORTED THAT THE SAFETY DEVICE OF A JELCO® PROTECTIVE® SAFETY I.V. CATHETER SEPARATES FROM THE HUB, CAUSING BLOOD TO FLOW OUT OF THE HUB. NO INJURY TO PATIENT OR CLINICIAN WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6732333 ↗
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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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