Jelco 305006Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of Jelco (101)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10351688071118), received between Mar 24, 2022 and Sep 16, 2025 — classified as 1 injury, 14 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak7
- Break3
- Difficult to Insert2
- Detachment of Device or Device Component1
- Patient Device Interaction Problem1
- Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- Needle Stick/Puncture1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT MULTIPLE IV CATHETERS LEAKED AND REQUIRED DISCONTINUING FROM PATIENT, AND A VISIBLE CRACK WAS SEEN DOWN THE SIDE OF EACH CATHETER. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23062839 ↗MalfunctionJun 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT PATIENT WAS ADMINISTERED WITH IV CATHETER, BUT UPON REMOVAL, IT WAS DISCOVERED THAT THE END PLASTIC CATHETER PIECE HAD DETACHED FROM THE HUB AND REMAINED LODGED IN THE PATIENT¿S ARM. VASCULAR SURGICAL INTERVENTION WAS REQUIRED TO REMOVE IT. THERE WAS PATIENT INVOLVEMENT AND PATIENT WAS UNABLE TO WORK FOR THE REMAINDER OF THE WEEK WITHOUT COMPENSATION DUE TO THE REQUIRED SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22302053 ↗MalfunctionFeb 21, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE DEVICE WAS LEAKING AND SPRAYING BLOOD FROM THE HUB AND THIS HAPPENED MULTIPLE TIMES WHILE STARTING IVS ON PATIENTS. THERE WERE NO PATIENT HARM OR ADVERSE EVENT REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21436774 ↗MalfunctionFeb 18, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE DEVICE WAS LEAKING AND SPRAYING BLOOD FROM THE HUB AND THIS HAPPENED MULTIPLE TIMES WHILE STARTING IVS ON PATIENTS. THERE WERE NO PATIENT HARM OR ADVERSE EVENT REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21400775 ↗MalfunctionDec 16, 2024Break; Break
IT WAS REPORTED THAT THE CATHETER BROKE OFF IN THE PATIENT'S SKIN. THERE WAS A PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20938728 ↗MalfunctionNov 27, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE CATHETER LEAKED DURING USE WITH THE PATIENT. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20798552 ↗MalfunctionNov 27, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE CATHETER LEAKED DURING USE WITH THE PATIENT. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20798532 ↗MalfunctionNov 14, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE DEVICE WAS LEAKING AT THE JUNCTURE OF THE CATHETER AND HUB. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20689560 ↗MalfunctionNov 14, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE CATHETER WAS LEAKING BLOOD. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20688029 ↗InjuryMay 26, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT THE NEEDLE STUCK IN PATIENTS HAND. NO ADDITIONAL ADVERSE PATIENT EFFECTS. THIS EVENT WAS CONSIDERED A SERIOUS INJURY. RECEIVED ADDITIONAL INFORMATION STATING A NEEDLE WAS NOT STUCK IN CHILD'S HAND, IT WAS 3/4 OF THE PLASTIC INTRAVENOUS (IV) CATHETER THAT WAS RETAINED IN THE CHILD'S HAND UNTIL A GENERAL SURGEON WAS ABLE TO SAFELY REMOVE.
Patient problems: Needle Stick/Puncture
MAUDE report 17009157 ↗MalfunctionSep 11, 2022Separation Problem; Separation Problem
IT WAS REPORTED THAT THE NEEDLE CAME OUT THE SIDE DURING INSERTION. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15397868 ↗MalfunctionMar 30, 2022Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT THE CATHETER MALFUNCTIONED ON PATIENT THAT WAS A HARD POKE. THERE SEEMS TO BE A HOLE OR THE CATHETER IS NOT ATTACHED CORRECTLY, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13954452 ↗MalfunctionMar 30, 2022Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT THE CATHETER MALFUNCTIONED ON PATIENT THAT WAS A HARD POKE. THERE SEEMS TO BE A HOLE OR THE CATHETER IS NOT ATTACHED CORRECTLY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13950530 ↗MalfunctionMar 24, 2022Break; Break
IT WAS REPORTED THAT UPON OPENING THE DEVICE, THEY WERE SHEARING UPON OPENING, REDNERING THEM UNUSABLE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13894340 ↗MalfunctionMar 24, 2022Break; Break
IT WAS REPORTED THAT UPON OPENING THE DEVICE, THEY WERE SHEARING UPON OPENING, REDNERING THEM UNUSABLE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13894329 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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