Jelco 3063Recalls & reported problems
Icu Medical, Inc. · GTIN FOR 306301 PROP 24 X 3/4 1/EA · Class 2
Quick summary
This ICU Medical Jelco 3063 is a short-term peripheral IV catheter. Its 37 reports mostly describe leaking — blood or saline escaping from the plastic hub or a crack in it, sometimes mid-infusion so the IV had to be removed and replaced — plus tears and hard insertion. No deaths were reported and 2 injuries were. No recalls name this device, and no reports were filed in the past 12 months.
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
- 37
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10351688071224), received between Jul 21, 2017 and Aug 20, 2025 — classified as 2 injuries, 35 malfunctions.
The most frequently reported specific device problem is “Defective Device” (10 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
- Defective Device10
- Fluid/Blood Leak7
- Material Split, Cut or Torn5
- Crack2
- Detachment of Device or Device Component2
- Difficult to Insert2
- Leak/Splash2
- Retraction Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- Insufficient Information2
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient2
- Anxiety1
- Device Embedded In Tissue or Plaque1
- Needle Stick/Puncture1
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 20, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT WHEN THE REGISTERED NURSE ASPIRATED TO CHECK FOR BLOOD RETURN, A SMALL AMOUNT OF BLOOD LEAKED FROM THE PLASTIC PART OF THE DEVICE WHERE THE CANNULA CONNECTED TO THE HUB. THE SKIN SITE SHOWED NO ISSUES. THIS OCCURRED DURING BLOOD ASPIRATION. THERE WAS PATIENT INVOLVEMENT, AND UNKNOWN SIGNS OR SYMPTOMS EXPERIENCED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22853932 ↗MalfunctionAug 20, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT WHEN THE REGISTERED NURSE ASPIRATED TO CHECK FOR BLOOD RETURN, A SMALL AMOUNT OF BLOOD LEAKED FROM THE PLASTIC PART OF THE DEVICE WHERE THE CANNULA CONNECTED TO THE HUB. THE SKIN SITE SHOWED NO ISSUES. THIS OCCURRED DURING BLOOD ASPIRATION. THERE WAS PATIENT INVOLVEMENT, AND UNKNOWN SIGNS OR SYMPTOMS EXPERIENCED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22853928 ↗MalfunctionAug 20, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT WHEN THE REGISTERED NURSE ASPIRATED TO CHECK FOR BLOOD RETURN, A SMALL AMOUNT OF BLOOD LEAKED FROM THE PLASTIC PART OF THE DEVICE WHERE THE CANNULA CONNECTED TO THE HUB. THE SKIN SITE SHOWED NO ISSUES. THIS OCCURRED DURING MEDICATION INFUSION OF IRON AND VEDOLIZUMAB. THERE WAS PATIENT INVOLVEMENT, AND UNKNOWN SIGNS OR SYMPTOMS EXPERIENCED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22853914 ↗MalfunctionAug 20, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT WHEN THE REGISTERED NURSE ASPIRATED TO CHECK FOR BLOOD RETURN, A SMALL AMOUNT OF BLOOD LEAKED FROM THE PLASTIC PART OF THE DEVICE WHERE THE CANNULA CONNECTED TO THE HUB. THE SKIN SITE SHOWED NO ISSUES. THIS OCCURRED DURING MEDICATION INFUSION OF IRON AND VEDOLIZUMAB. THERE WAS PATIENT INVOLVEMENT, AND UNKNOWN SIGNS OR SYMPTOMS EXPERIENCED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22853912 ↗MalfunctionAug 20, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT WHEN THE REGISTERED NURSE ASPIRATED TO CHECK FOR BLOOD RETURN, A SMALL AMOUNT OF BLOOD LEAKED FROM THE PLASTIC PART OF THE DEVICE WHERE THE CANNULA CONNECTED TO THE HUB. THE SKIN SITE SHOWED NO ISSUES. THIS OCCURRED DURING MEDICATION INFUSION OF IRON AND VEDOLIZUMAB. THERE WAS PATIENT INVOLVEMENT, AND UNKNOWN SIGNS OR SYMPTOMS EXPERIENCED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22853905 ↗MalfunctionJun 14, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT WHILE THE HEALTHCARE PROVIDER WAS FLUSHING THE CATHETER WITH A SALINE SOLUTION, THE SALINE CAME OUT FROM THE CATHETER. THE IV SOLUTION THEN REQUIRED REMOVAL AND ADDITIONAL OF PERIPHERAL STICKS TWICE IN ORDER TO OBTAIN ACCESS. THERE WAS NO PATIENT HARM OR INJURY BEING REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22208148 ↗MalfunctionOct 3, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT THE PERIPHERAL IV CATHETER PLASTIC HUB HAD A CRACK IN IT THAT WHEN PLACING THE IV, STARTED BLEEDING THROUGH THE CRACK OF THE IV HUB. PATIENT WAS NOT HARMED AND NOT DISTRESSED BUT IV HAD TO BE REMOVED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20359493 ↗MalfunctionJul 18, 2024Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT WHEN FLUSHED A HOLE IN THE CATHETER WAS FOUND WHEN BLOOD SHOT OUT. ADVERSE PATIENT EFFECTS ARE UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19776089 ↗MalfunctionJun 25, 2024Crack; Leak/Splash; Crack; Leak/Splash
IT WAS REPORTED THAT BLEEDING WAS NOTED FROM YELLOW HUB OF IV AND NOT FROM THE ACTUAL CONNECTION. THE IV WAS FOUND TO BE CRACKED AND THEREFORE LEAKING. THERE WAS PATIENT INVOLVEMENT AND NO APPARENT PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19610695 ↗MalfunctionMay 20, 2024Separation Failure; Separation Failure
IT WAS REPORTED THAT THE "CATHETER HUB WAS FUSED" AND FOUND DURING PATIENT USE. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19351016 ↗MalfunctionMay 13, 2024Failure to Disconnect; Failure to Disconnect
IT WAS REPORTED THAT THE YELLOW HUB WOULDN'T DETACH FROM THE IV CATHETER. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19304063 ↗MalfunctionFeb 28, 2024
NOTED BLOOD RETURN, NEEDLE ENGAGED IN SAFETY BUT COULD NOT SEPARATE CATHETER HUB FROM NEEDLE SAFETY MECHANISM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18796542 ↗MalfunctionJun 21, 2023Product Quality Problem; Product Quality Problem
IT WAS REPORTED, THAT THE PRODUCT TEARS THE PATIENTS SKIN UPON ENTRY. MAKING VENIPUNCTURE DIFFICULT AND REQUIRING SEVERAL ATTEMPTS. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17176293 ↗MalfunctionApr 6, 2023Difficult to Insert; Connection Problem; Difficult to Insert; Connection Problem
IT WAS REPORTED PER ANVISA (B)(4) THAT THE PRODUCT IS DIFFICULT TO USE, WITHOUT SHARPED BLADE, WITH DEFECTIVE COUPLING REQUIRING THE PATIENT TO BE PUNCTURED SEVERAL TIMES.
Patient problems: Needle Stick/Puncture
MAUDE report 16694601 ↗MalfunctionAug 23, 2022Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THERE WERE MULTIPLE REPORTS OF CATHETER SHEERING UPON INSERTION OVER THE LAST FEW MONTHS. NO PATIENT INJURY AND NO RETURN PRODUCT WAS ADDITIONALLY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15278359 ↗MalfunctionAug 23, 2022Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THERE WERE MULTIPLE REPORTS OF CATHETER SHEERING UPON INSERTION OVER THE LAST FEW MONTHS. NO PATIENT INJURY AND NO RETURN PRODUCT WAS ADDITIONALLY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15278286 ↗MalfunctionAug 23, 2022Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THERE WERE MULTIPLE REPORTS OF CATHETER SHEERING UPON INSERTION OVER THE LAST FEW MONTHS. NO PATIENT INJURY AND NO RETURN PRODUCT WAS ADDITIONALLY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15277967 ↗MalfunctionAug 23, 2022Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THERE WERE MULTIPLE REPORTS OF CATHETER SHEERING UPON INSERTION OVER THE LAST FEW MONTHS. NO PATIENT INJURY AND NO RETURN PRODUCT WAS ADDITIONALLY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15277947 ↗MalfunctionMay 12, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT UPON INSERTION OF IV DEVICE, CLINICIANS GOT A FLASH OF BLOOD BUT WERE UNABLE TO FLUSH/DRAW BLOOD ASSUMING A BLOCKAGE IN THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14382903 ↗MalfunctionApr 18, 2022Defective Device; Defective Device
IT WAS REPORTED THAT THERE WERE NINE ATTEMPTS TO PLACE AN IV. THE INITIAL ATTEMPT AND SECOND ATTEMPT DID NOT RESULT IN BLOOD RETURN. THE CAT SCAN DEPARTMENT HAD NO ISSUES GETTING A VEIN BUT THE IV SAFETY CATHETERS WOULD NOT DISCONNECT AND THE ENTIRE IV WOULD COME OUT IN ONE PIECE. THIS OCCURRED FOUR TIMES. ADDITIONAL ATTEMPTS WERE MADE ON A BED SHEET TO SEE IF THE IV CATHETER COULD DISCONNECT AND IT WOULD NOT. AFTER EIGHT ATTEMPTS OF STARTING AN IV SITE THE PATIENT WAS STARTED. AFTER THE PATIENT'S SCAN WAS STARTED THE IV SITE STOPPED WORKING 37 MINUTES INTO THE TEST. THE SITE WAS INSERTED WITH AN ULTRASOUND AND A NEW BOX OF CATHETERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14137144 ↗MalfunctionApr 18, 2022Defective Device; Defective Device
IT WAS REPORTED THAT THERE WERE NINE ATTEMPTS TO PLACE AN IV. THE INITIAL ATTEMPT AND SECOND ATTEMPT DID NOT RESULT IN BLOOD RETURN. THE CAT SCAN DEPARTMENT HAD NO ISSUES GETTING A VEIN BUT THE IV SAFETY CATHETERS WOULD NOT DISCONNECT AND THE ENTIRE IV WOULD COME OUT IN ONE PIECE. THIS OCCURRED FOUR TIMES. ADDITIONAL ATTEMPTS WERE MADE ON A BED SHEET TO SEE IF THE IV CATHETER COULD DISCONNECT AND IT WOULD NOT. AFTER EIGHT ATTEMPTS OF STARTING AN IV SITE THE PATIENT WAS STARTED. AFTER THE PATIENT'S SCAN WAS STARTED THE IV SITE STOPPED WORKING 37 MINUTES INTO THE TEST. THE SITE WAS INSERTED WITH AN ULTRASOUND AND A NEW BOX OF CATHETERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14137119 ↗MalfunctionApr 18, 2022Defective Device; Defective Device
IT WAS REPORTED THAT THERE WERE NINE ATTEMPTS TO PLACE AN IV. THE INITIAL ATTEMPT AND SECOND ATTEMPT DID NOT RESULT IN BLOOD RETURN. THE CAT SCAN DEPARTMENT HAD NO ISSUES GETTING A VEIN BUT THE IV SAFETY CATHETERS WOULD NOT DISCONNECT AND THE ENTIRE IV WOULD COME OUT IN ONE PIECE. THIS OCCURRED FOUR TIMES. ADDITIONAL ATTEMPTS WERE MADE ON A BED SHEET TO SEE IF THE IV CATHETER COULD DISCONNECT AND IT WOULD NOT. AFTER EIGHT ATTEMPTS OF STARTING AN IV SITE THE PATIENT WAS STARTED. AFTER THE PATIENT'S SCAN WAS STARTED THE IV SITE STOPPED WORKING 37 MINUTES INTO THE TEST. THE SITE WAS INSERTED WITH AN ULTRASOUND AND A NEW BOX OF CATHETERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14137090 ↗MalfunctionApr 18, 2022Defective Device; Defective Device
IT WAS REPORTED THAT THERE WERE NINE ATTEMPTS TO PLACE AN IV. THE INITIAL ATTEMPT AND SECOND ATTEMPT DID NOT RESULT IN BLOOD RETURN. THE CAT SCAN DEPARTMENT HAD NO ISSUES GETTING A VEIN BUT THE IV SAFETY CATHETERS WOULD NOT DISCONNECT AND THE ENTIRE IV WOULD COME OUT IN ONE PIECE. THIS OCCURRED FOUR TIMES. ADDITIONAL ATTEMPTS WERE MADE ON A BED SHEET TO SEE IF THE IV CATHETER COULD DISCONNECT AND IT WOULD NOT. AFTER EIGHT ATTEMPTS OF STARTING AN IV SITE THE PATIENT WAS STARTED. AFTER THE PATIENT'S SCAN WAS STARTED THE IV SITE STOPPED WORKING 37 MINUTES INTO THE TEST. THE SITE WAS INSERTED WITH AN ULTRASOUND AND A NEW BOX OF CATHETERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14137084 ↗MalfunctionApr 18, 2022Defective Device; Defective Device
IT WAS REPORTED THAT THERE WERE NINE ATTEMPTS TO PLACE AN IV. THE INITIAL ATTEMPT AND SECOND ATTEMPT DID NOT RESULT IN BLOOD RETURN. THE CAT SCAN DEPARTMENT HAD NO ISSUES GETTING A VEIN BUT THE IV SAFETY CATHETERS WOULD NOT DISCONNECT AND THE ENTIRE IV WOULD COME OUT IN ONE PIECE. THIS OCCURRED FOUR TIMES. ADDITIONAL ATTEMPTS WERE MADE ON A BED SHEET TO SEE IF THE IV CATHETER COULD DISCONNECT AND IT WOULD NOT. AFTER EIGHT ATTEMPTS OF STARTING AN IV SITE THE PATIENT WAS STARTED. AFTER THE PATIENT'S SCAN WAS STARTED THE IV SITE STOPPED WORKING 37 MINUTES INTO THE TEST. THE SITE WAS INSERTED WITH AN ULTRASOUND AND A NEW BOX OF CATHETERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14137083 ↗MalfunctionApr 18, 2022Defective Device; Defective Device
IT WAS REPORTED THAT THERE WERE NINE ATTEMPTS TO PLACE AN IV. THE INITIAL ATTEMPT AND SECOND ATTEMPT DID NOT RESULT IN BLOOD RETURN. THE CAT SCAN DEPARTMENT HAD NO ISSUES GETTING A VEIN BUT THE IV SAFETY CATHETERS WOULD NOT DISCONNECT AND THE ENTIRE IV WOULD COME OUT IN ONE PIECE. THIS OCCURRED FOUR TIMES. ADDITIONAL ATTEMPTS WERE MADE ON A BED SHEET TO SEE IF THE IV CATHETER COULD DISCONNECT AND IT WOULD NOT. AFTER EIGHT ATTEMPTS OF STARTING AN IV SITE THE PATIENT WAS STARTED. AFTER THE PATIENT'S SCAN WAS STARTED THE IV SITE STOPPED WORKING 37 MINUTES INTO THE TEST. THE SITE WAS INSERTED WITH AN ULTRASOUND AND A NEW BOX OF CATHETERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14137082 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.