Jelco 3083Recalls & reported problems
Icu Medical, Inc. · GTIN for 308300 PROPW 24 X 5/8 1/EA · Class 2
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10351688071361), received between May 22, 2018 and Sep 9, 2024 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Dull, Blunt4
- Fluid/Blood Leak2
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient3
- Hemorrhage/Blood Loss/Bleeding1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2024Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT WHILE INITIATING IV, TO PATIENT IT WAS UNABLE TO THREAD, WAS TRIED A SECOND TIME AND STILL WAS UNABLE. WHEN REMOVED, CATHETER WAS PUNCTURED WITH NEEDLE. PATIENT NEEDED A SECOND POKE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20172895 ↗MalfunctionJun 24, 2024
24 G IV PLACED IN PATIENT'S HAND WHEN FLUSHED A HOLE IN THE CATHETER WAS FOUND WHEN BLOOD SHOT OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19593557 ↗MalfunctionApr 29, 2024
INSERTED #24G IV INTO THE HAND, BEAUTIFUL FLASH, THEN CATHETER APPEARED TO BREAK AND BLOOD BEGAN OOZING OUT OF CATHETER AS REGISTERED NURSE (RN) ADVANCED CATHETER. WHEN RN ATTEMPTED TO OBTAIN LABS WHILE CATHETER NOT FULLY ADVANCED A "SUCTION" SOUND WAS HEARD FROM THE EXPOSED CATHETER. IT WAS THEN REMOVED AND OBSERVED TO BE BENT / BROKEN.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 19201998 ↗MalfunctionOct 31, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE HUB WAS LEAKING. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15699676 ↗MalfunctionMay 31, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT FOLLOWING INSERTION OF AN IV CATHETER, IV WAS NOTED TO BE LEAKING FROM WHERE THE HUB OF THE IV CONNECTS TO THE CANNULA. THE IV HAD TO BE REMOVED. NO APPARENT HARM TO THE PATIENT. NO OTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14547573 ↗MalfunctionJun 29, 2018Dull, Blunt; Dull, Blunt
INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PERIPHERAL INTRAVENOUS CATHETER WAS DULL ON INSERTION. NO ADVERSE EFFECTS WERE EXPERIENCED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7652300 ↗MalfunctionJun 29, 2018Dull, Blunt; Dull, Blunt
INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PERIPHERAL INTRAVENOUS CATHETER WAS DULL ON INSERTION. NO ADVERSE EFFECTS WERE EXPERIENCED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7652291 ↗MalfunctionJun 29, 2018Dull, Blunt; Dull, Blunt
INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PERIPHERAL INTRAVENOUS CATHETER WAS DULL ON INSERTION. NO ADVERSE EFFECTS WERE EXPERIENCED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7652143 ↗MalfunctionMay 22, 2018Dull, Blunt; Dull, Blunt
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL JELCO® PROTECTIV® SAFETY I.V. CATHETER WAS NOTED NOT TO BE SHARP ENOUGH TO INSERT INTO THE PATIENT. IT WAS REPORTED THAT THE IV IS NOT SMOOTH TO INSERT INTO THE SKIN; CAUSED FAILED VEIN PUNCTURE. THERE WERE NO REPORTED ADVERSE EFFECTS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7534311 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.