Jelco 405311Recalls & 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
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 15019315118340), received between Feb 7, 2020 and Nov 5, 2024 — classified as 3 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
- Break2
- Fluid/Blood Leak2
- Material Fragmentation2
- Material Puncture/Hole2
- Material Split, Cut or Torn2
- Defective Component1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Foreign Body In Patient2
- Device Embedded In Tissue or Plaque1
- Head Injury1
- Pain1
- Patient Problem/Medical Problem1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 5, 2024Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
IT WAS REPORTED THAT THE DEVICE WAS LEAKING AT THE CATHETER SITE, WHICH LOOKED TO HAVE HOLES IN IT. THERE WAS UNKNOWN PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20611235 ↗MalfunctionNov 5, 2024Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
IT WAS REPORTED THAT THE DEVICE WAS LEAKING AT THE CATHETER SITE, WHICH LOOKED TO HAVE HOLES IN IT. THERE WAS UNKNOWN PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20611045 ↗InjuryAug 12, 2024Defective Component; Defective Component
IT WAS REPORTED THAT THE CATHETER PIERCED IN SEVERAL PLACES NEAR THE PLASTIC JUNCTION. THIS CATHETER WAS LEFT IN PLACE FOR SCALP PERFUSION. IT CAUSED SIGNIFICANT INFILTRATION OF THE SCALP AND REINSTALLATION OF CATHETER WAS DONE FOR THE PATIENT AND THERE WAS SCALP INFILTRATE/PAIN. THERE WAS PATIENT INVOLVEMENT AND PATIENT HARM REPORTED.
Patient problems: Head Injury; Pain
MAUDE report 19962273 ↗MalfunctionAug 12, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE CATHETER PIERCED IN SEVERAL PLACES NEAR THE PLASTIC JUNCTION. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED. THE DEVICE IS AVAILABLE FOR INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19962246 ↗InjuryJul 29, 2020Break; Material Fragmentation; Break; Material Fragmentation
INFORMATION WAS RECEIVED INDICATING THAT UPON REMOVAL OF A SMITHS MEDICAL JELCO IV CATHETER, A PORTION OF THE CATHETER WAS FOUND MISSING. A SERIES OF RADIOGRAPHS WERE ORDERED AND PERFORMED, INDICATING THAT THE PIECE HAD MIGRATED INTO THE AREA OF THE SCAPULA. THE IV WAS REPORTED TO HAVE BEEN INITIALLY PLACED IN THE FRONT CEPHALIC VEIN AND THAT THE RETAINED PIECE HAS NOT BEEN REMOVED. COMPLAINTS OF PYREXIA POSTOPERATIVELY HAS BEEN NOTED WITH ANTIBIOTIC AND NSAID TREATMENT HAS BEEN PRESCRIBED. THERE HAVE BEEN NO FURTHER REPORTED ADVERSE EFFECTS.
Patient problems: Foreign Body In Patient
MAUDE report 10338873 ↗InjuryFeb 7, 2020Break; Material Fragmentation; Material Integrity Problem; Material Split, Cut or Torn; Break; Material Fragmentation; Material Integrity Problem; Material Split, Cut or Torn
IT WAS REPORTED THE RN ATTEMPTED TO INSERT IV CATHETER INTO PATIENT'S LEFT FOOT. WHILE PULLING BACK SLIGHTLY ON THE NEEDLE TO ADVANCE CATHETER, NURSE FELT NEEDLE PUNCTURE THE SIDE OF THE CATHETER WHILE THE CATHETER WAS INSERTED IN THE PATIENT. NURSE PULLED CATHETER & NEEDLE OUT OF PATIENT AND NOTICED PART OF THE CATHETER WAS MISSING AND STUCK INSIDE PATIENT'S FOOT." PROVIDERS CALLED TO BEDSIDE UNABLE TO REMOVE RETAINED PORTION OF CATHETER. X-RAY IMAGING SHOWED SMALL BROKEN CATHETER TIP ALONG THE MEDIAL ASPECT OF LEFT FOOT ADJACENT TO BASE OF 1ST METATARSAL. SUBSEQUENTLY, PLASTIC SURGERY WAS CONSULTED WITH INCISION MADE FOR REMOVAL ON (B)(6) 2019. NO FURTHER REPORTED ADVERSE PATIENT EFFECTS.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient; Patient Problem/Medical Problem
MAUDE report 9683507 ↗
Other Catheter,intravascular,therapeutic,short-term less than 30 days devices
- BD Insyte Autoguard 382523Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days660 reports
- BD Insyte Autoguard 382533Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls527 reports
- BD PosiFlush 306546Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 death608 reports
- BD Insyte Autoguard Shielded IV Catheter 381823Becton, Dickinson And Company · Catheter, intravascular, therapeutic, short-term less than 30 days582 reports
- BD Insyte Autoguard 381423Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall528 reports
- BD Insyte Autoguard 382544Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall437 reports
- BD Nexiva, BD Q-Syte 383536Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls374 reports
- BD PosiFlush 306547Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls1 death331 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page