Jelco 982512DRecalls & reported problems
Icu Medical, Inc. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20351688081794), received between Mar 25, 2025 and Jul 21, 2025 — classified as 2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Fracture1
- Retraction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 21, 2025Fracture; Fracture
IT WAS REPORTED WHEN CONNECTING THE HOLDER TO THE NEEDLESS CONNECTOR THE MALE LUER BROKE OFF. THE NEEDLESS CONNECTOR WAS ATTACHED TO A HICKMAN CATHETER. THE HICKMAN CATHETER WAS CAPPED WITH NEEDLELESS CONNECTORS. THE BLOOD COLLECTION DEVICE WAS ATTACHED TO THE HICKMAN AND THE TUBES THEN ATTACHED TO THE COLLECTOR DEVICE. THEY USED JUST THE HOLDER AND LUER IT TO THE NEEDLELESS CONNECTOR THEN UTILIZES VACUUM TUBES TO OBTAIN SAMPLES. THE DEVICE BROKE OFF INTO THE PATIENT WAS THE LUER CONNECTOR THAT SCREWS ON/INTO THE PORT OF THE HICKMAN WAS BROKE INTO THE CATHETER AND COULD NOT BE REMOVED. THE EVENT OCCURRED WHILE IN USE WITH PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22556609 ↗MalfunctionMar 25, 2025Break; Retraction Problem; Break; Retraction Problem
IT WAS REPORTED THAT WHEN THE NEEDLE WAS RETRACTED A CLICK WAS HEARD BUT A PORTION OF THE NEEDLE REMAINED EXPOSED. IT WAS ALSO INFORMING THAT THE NEEDLE HAD SIMILAR FAILURE TO FULLY ENGAGE SAFELY. BOTH SITUATIONS RESULTED IN CLINICIAN'S NEEDLE STICKS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21688855 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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