Jelco 982112DRecalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20351688081756), received between Jun 29, 2017 and Aug 31, 2022 — classified as 4 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.
Most reported problems
Device problems
- Break2
- Detachment of Device or Device Component2
- Device Difficult to Setup or Prepare1
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 31, 2022Peeled/Delaminated; Device Difficult to Setup or Prepare; Detachment of Device or Device Component; Peeled/Delaminated; Device Difficult to Setup or Prepare; Detachment of Device or Device Component
IT WAS REPORTED THAT THREADING OCCURRED WHEN CONNECTING THE VACUTAINER TO THE NEEDLE. THERE WERE TWO (2) ACCIDENTAL NEEDLE POKES DUE TO THE PLASTIC BAND THAT HELD THE TUBING IS DIFFICULT TO REMOVE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15327478 ↗MalfunctionAug 31, 2022Break; Break
IT WAS REPORTED THAT THE DEVICE HUB WAS BENDING OR BREAKING, WHICH HAPPENS AFTER MULTIPLE USAGES. ALSO, THERE WAS A REPORT OF THE BUTTERFLY NEEDLE SETS EXPLODING. THE RUBBER STOPPER PREVENTED BLOOD FROM COMING OUT WHEN THERE IS NOT A TUBE PRESSED INTO THE NEEDLE FOR FILLING. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15327212 ↗MalfunctionAug 31, 2022Break; Break
IT WAS REPORTED THAT THE DEVICE HUB WAS BENDING OR BREAKING, WHICH HAPPENS AFTER MULTIPLE USAGES. ALSO, THERE WAS A REPORT OF THE BUTTERFLY NEEDLE SETS EXPLODING. THE RUBBER STOPPER PREVENTED BLOOD FROM COMING OUT WHEN THERE IS NOT A TUBE PRESSED INTO THE NEEDLE FOR FILLING. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15326817 ↗MalfunctionJun 29, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED AFTER A BLOOD DRAW, THE NURSE WENT TO REMOVE THE BUTTERFLY NEEDLE OF A JELCO® SAF-T WING® BLOOD COLLECTION AND INFUSION SET FROM THE PATIENT'S VEIN AND THE NEEDLE SEPARATED FROM THE PLASTIC OF THE BUTTERFLY AND REMAINED IN THE PATIENT'S VEIN. THE NURSE THEN REMOVED THE NEEDLE FROM THE PATIENT'S VEIN AND DISCARDED IN THE SHARPS CONTAINER. NO INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6678485 ↗
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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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