Jelco 96000Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of Jelco (101)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This ICU Medical Jelco 96000 is a blood collection adapter used to draw blood into lab tubes. The 50 reports mostly describe the plastic cracking or breaking apart — sometimes while still attached to a patient's IV hub or central line, so pieces stayed stuck and a patient's line had to be replaced. Reports also describe blood leaking or failing to flow into the tube, and adapters stuck on lines. There are 3 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 50
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 20351688062953), received between Jul 12, 2017 and Nov 21, 2025 — classified as 3 injuries, 47 malfunctions.
The most frequently reported specific device problem is “Break” (31 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
- Break31
- Use of Device Problem5
- Fluid/Blood Leak3
- Blocked Connection2
- Defective Device2
- Difficult to Remove2
- Product Quality Problem2
- Separation Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions47
- Insufficient Information2
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 21, 2025Blocked Connection; Separation Problem; Blocked Connection; Separation Problem
IT WAS REPORTED THAT THE BLOOD IS NOT ABLE TO FLOW THROUGH THE DEVICE TO FILL LAB TUBES. WHEN REMOVED PART OF THE VACUTAINER REMAINED IN THE LAB VIAL. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23622207 ↗InjuryJul 15, 2025Break; Difficult to Remove; Break; Difficult to Remove
IT WAS REPORTED THAT THE DEVICE WAS STUCK AT THE END OF THE CENTRAL LINE, AND IT BROKE APART WHEN THE NURSE UNSCREWED IT. REPORTER STATED THAT A PATIENT HAD TO HAVE THEIR CENTRAL LINE REPLACED BECAUSE THEY COULD NOT REMOVE THE BROKEN PLASTIC FROM THE END OF HIS LINE. THE OUTCOME OF THE EVENT IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 22507212 ↗MalfunctionJul 8, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE VACUTAINER CRACKED WHILE IN USE. NO MEDICAL INTERVENTION WAS PROVIDED REPORTED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22437674 ↗InjuryMay 23, 2025Break; Difficult to Remove; Break; Difficult to Remove
IT WAS REPORTED THAT THEIR NURSE HAD ISSUES WITH THE CLEAR TIPPED ADAPTER WHICH INCLUDES THE DEVICE BEING STUCK AT THE END OF THE CENTRAL LINE AND IT BROKE APART WHEN THE NURSE UNSCREWED IT. A PATIENT HAD TO HAVE THEIR CENTRAL LINE REPLACED BECAUSE THEY COULD NOT REMOVE THE BROKEN PLASTIC FROM THE END OF HIS LINE. NO MEDICAL INTERVENTION WAS PROVIDED. THE OUTCOME OF THE EVENT IS UNKNOWN. IT'S STILL UNKNOWN IF PATIENT WAS INJURED OR THERE WAS CLINICAL INJURY DURING PRODUCT FAULT OCCURRED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22075788 ↗MalfunctionFeb 7, 2025Blocked Connection; Separation Problem; Blocked Connection; Separation Problem
IT WAS REPORTED THAT THE BLOOD IS NOT ABLE TO FLOW THROUGH THE DEVICE TO FILL LAB TUBES. WHEN REMOVED PART OF THE VACUTAINER REMAINED IN THE LAB VIAL. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21335724 ↗MalfunctionDec 27, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT WHEN THE TUBE IS INSERTED INTO THE SAF-T HOLDER DEVICE, THE TUBE DOES NOT FILL WITH BLOOD AS IT SHOULD. THEN WHEN THE TUBE IS REMOVED, BLOOD BEGAN TO FLOW OUT OF THE SAF-T HOLDER DEVICE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21029073 ↗MalfunctionApr 5, 2024
ELDERLY FEMALE WITH HISTORY OF RECENT EXTERNAL FIXATION OF RIGHT LOWER EXTREMITY. PROCEDURE: LAB DRAW FROM IV HUB. FEMALE ADAPTOR BROKE WHILE USING TO DRAW LABS. PLASTIC PIECE STAYED STUCK IN PATIENT¿S IV HUB, REMOVED WITHOUT HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19049623 ↗MalfunctionNov 7, 2023
ELDERLY MALE IN ED (EMERGENCY DEPARTMENT) WITH SUDDEN ONSET OF CONFUSION AND VISUAL IMPAIRMENT. PROCEDURE: IV INFUSION- IV ADAPTER STUCK IN THE HUB OF SAF-T HOLDER DEVICE. THE ADAPTER BROKE WHILE TRYING TO REMOVE THE LOOP. ANOTHER ADAPTER AND LOOP USED WITHOUT DIFFICULTY. NO KNOWN HARM TO PATIENT, DELAY IN CARE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18083301 ↗MalfunctionJun 28, 2023Break; Break
IT WAS REPORTED, THAT THE INNER COLLARS WERE BREAKING OFF AND GETTING JAMMED IN THE CVC CAP. CAUSING THE CVC CAP TO STAY OPEN, ALLOWING BLOOD TO LEAK OUT. WHEN ATTEMPTING TO DISCONNECT THE VACUTAINER FROM PICC CAP, THE VACUTAINER INNER CANNULA BROKE OFF. AND LODGED IN PICC LUER-LOCK CAP. THIS WAS THE THIRD VACUTAINER TO BREAK OFF IN THE CAP, DURING BLOOD DRAW. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17216652 ↗MalfunctionMar 16, 2023Contamination; Contamination
IT WAS REPORTED PER MW5105872: A NURSE REMOVED SAF-T HOLDER DEVICE AND WENT TO FLUSH THE CENTRAL LINE TO CLEAR IT OF BLOOD AND NOTICED THAT THERE WAS A WHITE PIECE OF SOMETHING IN THE VALVE ON THE IV LINE AND NOTICED AIR MOVING FROM THE VALVE TO THE PATIENT. THE LINE WAS CLEARED WITH NO INCIDENT. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16560013 ↗MalfunctionSep 19, 2022Defective Device; Defective Device
IT WAS REPORTED THAT IN CONJUNCTION WITH THE PVK SETTING WITH BLUE NEXIVA, BLOOD CULTURE IS TAKEN FROM THE PVK BY MEANS OF SAFTHOLDER WHICH IS CONNECTED TO THE PVK AND THE BLOOD SAMPLES ARE TAKEN. WHEN THE SAFTHOLDER IS THEN DISCONNECTED FROM THE PVK, IT HAS BROKEN AND A PIECE OF PLASTIC REMAINS IN THE PVK MOUTH. UNABLE TO REMOVE PLASTIC AND HOSE TO PVK MUST BE REPLACED. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15445301 ↗MalfunctionSep 17, 2022Break; Break
IT WAS REPORTED THAT DURING BLOOD SAMPLING WITH A NEEDLE, THE TIP BROKE INSIDE THE NEEDLE'S TWO WAY VALVE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15442986 ↗MalfunctionSep 11, 2022Break; Break
IT WAS REPORTED THAT THE HOLDER BROKE INSIDE THE INFUSION'S EXTENSION LINE LEAVING BLOOD RESIDUE INSIDE THE EXTENSION LINE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15397989 ↗MalfunctionSep 11, 2022Break; Break
IT WAS REPORTED THE VACUTAINER BROKE AT THE TIP. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15397987 ↗MalfunctionSep 11, 2022Break; Break
IT WAS REPORTED THAT UPON REMOVAL THE HOLDER END PIECE (LOCK) BROKE OFF. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15397983 ↗MalfunctionSep 11, 2022Break; Break
IT WAS REPORTED THAT UPON REMOVAL THE HOLDER END PIECE (LOCK) BROKE OFF. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15397979 ↗MalfunctionSep 11, 2022Break; Break
IT WAS REPORTED THAT UPON REMOVAL THE HOLDER END PIECE (LOCK) BROKE OFF. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15397976 ↗MalfunctionSep 11, 2022Break; Break
IT WAS REPORTED THAT THE INNER COLLARS WERE BREAKING OFF AND GETTING JAMMED IN THE CVC CAP CAUSING THE CVC CAP TO STAY OPEN ALLOWING BLOOD TO LEAK OUT. WHEN ATTEMPTING TO DISCONNECT VACUTAINER FROM PICC CAP, VACUTAINER'S INNER CANNULA BROKE OFF AND LODGED IN PICC LUER-LOCK CAP. THIS WAS THE THIRD VACUTAINER TO BREAK OFF IN THE CAP DURING BLOOD DRAW. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15397970 ↗MalfunctionSep 11, 2022Break; Break
IT WAS REPORTED THAT THE INNER COLLARS WERE BREAKING OFF AND GETTING JAMMED IN THE CVC CAP CAUSING THE CVC CAP TO STAY OPEN ALLOWING BLOOD TO LEAK OUT. WHEN ATTEMPTING TO DISCONNECT VACUTAINER FROM PICC CAP, VACUTAINER'S INNER CANNULA BROKE OFF AND LODGED IN PICC LUER-LOCK CAP. THIS WAS THE THIRD VACUTAINER TO BREAK OFF IN THE CAP DURING BLOOD DRAW. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15397865 ↗MalfunctionSep 11, 2022Break; Break
IT WAS REPORTED THAT THE HOLDER BROKE WHILE IN USE WITH A NEEDLE. THE NEEDLE WAS REMOVED AND A NEW ONE WAS USED. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15397864 ↗MalfunctionSep 11, 2022Disconnection; Disconnection
IT WAS REPORTED THAT, AFTER THE DEVICE WAS ATTACHED AND SAMPLES WERE OBTAINED FROM THE PICC LINE, THE NURSE TWISTED THE DEVICE TO FLUSH AND THE MALE LUER DISCONNECTED FROM THE HOLDER AND WAS LEFT IN THE PICC LINE LUMEN CAP. THE NURSE WAS UNABLE TO REMOVE THE BROKEN PIECE OUT TO THE CAP, THEREFORE THE BLUE CAP ON THE PICC LINE HAD TO BE REPLACED. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15397863 ↗MalfunctionSep 11, 2022Break; Break
IT WAS REPORTED THAT WHEN CONNECTING THE EXTENSION LINE TO THE CONNECTOR, THE CONNECTOR BROKE AT THE LUER. AIR BUBBLES WERE OBSERVED AND THEY HAD TO CHANGE THE LINE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15397862 ↗MalfunctionSep 11, 2022Break; Break
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE PORT WAS USED WITHOUT INFUSION LINE. THE VACUTAINER BROKE INSIDE THE ONE WAY VALVE DURING BLOOD SAMPLING. THE USER COULD NOT REMOVE THE VALVE AND HAD TO REMOVE THE NEEDLE WITHOUT RINSING. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15397861 ↗MalfunctionSep 11, 2022Break; Break
IT WAS REPORTED THAT THE INNER COLLARS WERE BREAKING OFF AND GETTING JAMMED IN THE CVC CAP CAUSING THE CVC CAP TO STAY OPEN ALLOWING BLOOD TO LEAK OUT. WHEN ATTEMPTING TO DISCONNECT THE VACUTAINER FROM PICC CAP, THE VACUTAINER INNER CANNULA BROKE OFF AND LODGED IN PICC LUER-LOCK CAP. THIS WAS THE THIRD VACUTAINER TO BREAK OFF IN THE CAP DURING BLOOD DRAW. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15397860 ↗MalfunctionSep 11, 2022Break; Break
IT WAS REPORTED THAT THE DEVICE BROKE INSIDE THE INFUSION EXTENSION LINE LEAVING BLOOD RESIDUE INSIDE THE EXTENSION LINE. THE USER COULD NOT RINSE AND HAD TO CHANGE THE NEEDLE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15397858 ↗
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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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