Jelco 3066Recalls & reported problems
Icu Medical, Inc. · GTIN for PROP 20 X 1 1/4 Each · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This ICU Medical Jelco catheter is a short-term IV catheter placed in a vein. Reports mostly describe difficult insertion with dull needles, catheters kinking, leaking or breaking, sometimes leaving fragments in the patient. There are 80 reports that name its identifier, with no deaths and 9 injuries. 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
- 80
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 10351688071170), received between Aug 7, 2017 and Jan 28, 2026 — classified as 9 injuries, 71 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (48 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
- Dull, Blunt48
- Product Quality Problem48
- Material Fragmentation5
- Break4
- Difficult to Insert4
- Fluid/Blood Leak4
- Difficult to Advance3
- Separation Failure3
Patient problems
- No Known Impact Or Consequence To Patient53
- No Clinical Signs, Symptoms or Conditions11
- Foreign Body In Patient5
- Pain4
- No Consequences Or Impact To Patient2
- No Information2
- Blood Loss1
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 25 most recent of 80 reports, in the reporter's own words as published by the FDA.
InjuryJan 28, 2026Break
IT WAS STATED THAT THE CATHETER BROKE OFF DURING UNSUCCESSFUL INSERTION/REMOVAL. A NURSE INSERTED AN INTRAVENOUS (IV) INTO LEFT ACROMIOCLAVICULAR (AC), IV BLEW, NURSE WENT TO REMOVE BLOWN IV AND THE CATHETER TIP BROKE OFF IN THE PATIENT¿S VEIN. A TOURNIQUET WAS APPLIED AND PRESSURE AS A PLAN WAS FORMED. PATIENT LATER WENT TO OPERATING ROOM (OR), AND THE CATHETER TIP WAS REMOVED WITHOUT COMPLICATIONS. THE ISSUE WAS NOTICED DURING THE REMOVAL OF THE CATHETER AFTER UNSUCCESSFUL IV INSERTION ATTEMPT. THERE WAS PATIENT INVOLVEMENT AND THERE WAS PATIENT HARM- REQUIRED SURGICAL INTERVENTION. THERE WAS NO DELAY IN PATIENT TREATMENT. THE OUTCOME OF THE EVENT WAS RESOLVED AS THE PATIENT UNDERWENT SURGERY AND WAS DISCHARGED.
Patient problems: Foreign Body In Patient
MAUDE report 24202005 ↗MalfunctionAug 27, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AFTER THE CATHETER WAS INSERTED, IT BECAME KINKED IN THE VEIN AT SOME POINT BETWEEN INSERTION AND REMOVAL, CAUSING LEAKAGE DURING IV CONTRAST INJECTION. THE EVENT OCCURRED DURING USE ON A PATIENT. THERE WAS PATIENT INVOLVEMENT, BUT ANY HARM OR ADVERSE EVENT REMAINS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22904015 ↗MalfunctionFeb 3, 2025Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT THE MATERIAL PRESENTED RESISTANCE WHEN INTRODUCED INTO THE BLOOD VESSEL, CAUSING RUPTURE. THERE WAS PATIENT INVOLVEMENT AND ACCORDING TO THE REPORT, THERE WAS DAMAGE TO THE PATIENT WHICH WAS DEFINED AS DUE TO THE RUPTURE OF THE BLOOD VESSEL. THE PROCEDURE HAD TO BE REPEATED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 21297290 ↗MalfunctionJan 27, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
IT WAS REPORTED THAT WHEN ADVANCING THE CATHETER NEAR THE HARD PINK PLASTIC THERE WAS A HOLE. THE HOLE PREVENTED BLOOD FROM BEING DRAWN, THE TUBES WOULD ONLY FILL HALFWAY AND FROTHY, ALSO BLOOD LEAKING FROM THE HOLE DRAWN, THE TUBES WOULD ONLY FILL HALFWAY. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21241124 ↗MalfunctionSep 27, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN OBSTETRIC INFUSION, THE MIDWIFE PULLED OUT THE CATHETER BECAUSE IT WASN'T IN THE VEIN. ON REMOVAL, THE CATHETER WAS BENT, AND THE NEEDLE HAD PIERCED IT. THERE WAS UNKNOWN PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20324486 ↗MalfunctionMay 16, 2024Disconnection; Device-Device Incompatibility; Disconnection; Device-Device Incompatibility
IT WAS REPORTED THAT THE CUSTOMER NEEDS TO TEST THE COMPATIBILITY OR MATING OF THE CATHETERS TO THEIR ITEM NUMBER. IT ALSO STATED THAT THEIR CUSTOMER IS SAYING THAT THE EXTENSION SET AND/OR MALE LUER POPS OFF THE CATHETER FEMALE LUER DURING CT INJECTION. THIS IS INTERMITTENT, BUT THEY HAVE SEEN AN INCREASE. THEY WANT TO VERIFY THAT ALL ITEMS ARE IN SPEC AND VALIDATE UNDER HIGH PRESSURE INJECTION. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED. DATE OF EVENT WAS IN MARCH/APRIL STILL ON GOING. THE EVENT OCCURS AT CT. AFFECTED QUANTITY 2 WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19331055 ↗MalfunctionAug 19, 2022Difficult to Advance; Physical Resistance/Sticking
WHEN INSERTING IV, CATHETER MET WITH RESISTANCE AND WAS REMOVED FROM THE RUE. THE CATHETER WAS NOTED TO BE SHORTER UPON REMOVAL. FDA SAFETY REPORT ID #(B)(4). SEE SCANNED PAGES.
Patient problems: Insufficient Information
MAUDE report 15265608 ↗MalfunctionAug 3, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT HE CUSTOMER EXPERIENCED THE IV LEAKING OUT THE SIDE OF THE CATHETER. NO FURTHER INFORMATION WAS PROVIDED. NO PATIENT INJURY OR ADVERSE AFFECTS WERE REPORTED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15156848 ↗MalfunctionMay 14, 2022Defective Device; Defective Device
IT WAS REPORTED THAT WHILE INSERTING THE INTRAVENOUS (IV) INTO THE PATIENT, THE NEEDLE DID NOT RETRACT INTO THE SAFETY COMPARTMENT. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14402915 ↗MalfunctionMay 13, 2022Defective Component; Defective Component
IT WAS REPORTED THAT WHEN REMOVING THE MECHANISM, IT CLICKED BUT NOT THE SAME SOUND AS ALWAYS AND GENERATED A LITTLE RESISTANCE TO REACH THE END- LEAVING PART OF THE NEEDLE OUT. THERE HAVE BEEN TWO CASES REPORTED, ONE CAUSED A PUNCTURE AND THE OTHER DID NOT. NO PATIENT INJURY WAS REPORTED FOR THIS CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14397451 ↗MalfunctionApr 14, 2022Component Missing; Component Missing
IT WAS REPORTED THAT UPON OPENING THE PRODUCT, THERE WAS NO NEEDLE WITHIN THE CATHETER. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14111241 ↗MalfunctionFeb 1, 2022Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT DURING THE PLACEMENT OF THE CATHETER, IT WAS DIFFICULT TO ACCESS TO THE VEIN OF THE PATIENT. THERE WAS RESISTANCE, ONCE IN THE VEIN, AND IF YOU FORCE, THERE IS A RISK OF HEMATOMA OR EXTRAVASATION AT THE INJECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13418348 ↗MalfunctionJan 21, 2022Break; Break
IT WAS REPORTED THAT THE IV CATHETER BREAK AND MIGRATE (PROTECTIV PLUS, 3060). THEY WERE UNABLE TO RETRIEVE IT. THEY WILL SCAN HIM IN 2 WEEKS TO SEE IF THEY CAN FIND IT. LOOKS LIKE IT SNAPPED RIGHT NEAR THE CONNECTION TO THE HUB BUT THERE IS A STRANGE LITTLE CURL OF PLASTIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13314814 ↗MalfunctionSep 23, 2021Break; Component Missing; Break; Component Missing
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PERIPHERAL INTRAVENOUS CATHETERS (PIVC)/JELCO SAFETY PROTECTIV PLUS CATHETER APPEARED SHORT UPON REMOVAL. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12521386 ↗InjuryNov 1, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A SMITHS MEDICAL CATHETER WAS LEAKING FROM THE HUB WAS OBSERVED; REQUIRING THE CATHETER TO BE SURGICALLY REMOVED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Information
MAUDE report 10767629 ↗InjurySep 14, 2020Material Fragmentation; Material Fragmentation
INFORMATION WAS RECEIVED INDICATING THAT UPON REMOVAL OF A SMITHS MEDICAL JELCO SAFETY PROTECTIVE PLUS CATHETER, THE CATHETER BROKE OFF AT THE HUB, LEAVING THE TIP IN THE CEPHALIC VEIN. VASCULAR SURGERY WAS REPORTED TO REMOVE THE FRAGMENT IN THE OPERATING ROOM. THERE WERE NO FURTHER REPORTED ADVERSE EFFECTS.
Patient problems: Foreign Body In Patient
MAUDE report 10532245 ↗InjurySep 19, 2019Material Fragmentation; Material Fragmentation
INFORMATION WAS RECEIVED THAT WHILE A SMITHS MEDICAL CATHETER WAS IN USE, PATIENT NOTICED BLOOD POOLING AT IV SITE, AND IT WAS SUBSEQUENTLY REMOVED. HOWEVER, IT WAS REPORTED THAT WHILE ATTEMPTING TO DO SO, THE CANNULA DI NOT WITHDRAW FROM THE PATIENT'S VEIN. ALCOHOL WAS USED TO DETERMINE IF CANNULA COULD BE SEEN. PRESSURE WAS GIVEN TO THE ARM AND A TOURNIQUET APPLIED TO SITE; NAILBED CAPILLARY WAS MONITORED. PATIENT WAS TAKEN TO SURGERY FOR REMOVAL OF DETACHED CANNULA. IT WAS ALSO REPORTED THAT NO FOREIGN BODY COULD BE SEEN ON CT OR FILM. THE SURGERY WAS UNSUCCESSFUL HOWEVER. NO FURTHER ADVERSE EFFECTS REPORTED.
Patient problems: Blood Loss
MAUDE report 9088756 ↗MalfunctionApr 8, 2019Device Alarm System; Difficult to Advance; Device Alarm System; Difficult to Advance
INFORMATION WAS RECEIVED THAT WHILE A SMITHS MEDICAL CATHETER WAS IN USE, DEVICE WAS DIFFICULT TO THREAD. NO PATIENT INJURY RESULTED.
Patient problems: No Consequences Or Impact To Patient; No Information
MAUDE report 8494216 ↗MalfunctionApr 5, 2019Difficult to Insert; Difficult to Insert
INFORMATION WAS RECEIVED INDICATING THAT CLINICIANS ARE EXPERIENCING ISSUES THREADING A SMITHS MEDICAL PERIPHERAL INTRAVENOUS CATHETER. THERE WAS NO REPORTED INJURY TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8488655 ↗InjuryMar 24, 2019Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component
INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL JELCO PROTECTIV SAFETY I.V. CATHETER WAS INSERTED INTO A PATIENT ON (B)(6) 2019. UPON REMOVAL OF THE IV DRESSING, IT WAS IMMEDIATELY NOTED THAT ONLY THE BLUE PLASTIC HUB OF THE IV DEVICE WAS ATTACHED TO THE IV EXTENSION AND THE IV CATHETER WAS NOT ATTACHED TO THE HUB. A TOURNIQUET WAS IMMEDIATELY PLACED ON THE PATIENT'S UPPER ARM. X-RAY IMAGES AND ULTRASONOGRAPHY REVEALED THAT THE ONE INCH CATHETER WAS STILL IN THE PATIENT'S RIGHT FOREARM. SUBSEQUENTLY, THE PATIENT HAD TO UNDERGO A SURGICAL PROCEDURE FOR REMOVAL OF THE CATHETER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 8446737 ↗MalfunctionMar 18, 2019Separation Problem; Separation Problem
INFORMATION WAS RECEIVED THAT UPON REMOVAL OF SMITHS MEDICAL CATHETER, DEVICE TIP WAS NOTED TO BE MISSING. ULTRA SOUND WAS DONE, AND XRAY OF THE PATIENT'S ARM WAS ABLE TO LOCATE THE MISSING PIECE. HOWEVER, IT WAS REPORTED THAT " A FOLLOW UP XRAY OF THE ELBOW AND A CT OF THE CHEST DONE ON 02/06/2019 AND WERE BOTH (B)(6) FOR VISUALIZATION". ADDITIONALLY, " PATIENT WAS STABLE FOR DISCHARGE FROM ORIGINAL DIAGNOSIS, BUT ATTENDING ORDERED A STAT ULTRASOUND PRIOR TO DISCHARGE TO ASSESS FOR CATHETER". PATENT DECLINED FOLLOW UP CARE OF ANOTHER ULTRA SOUND AGAINST MEDICAL ADVICE. NEXT DAY CASE MANAGEMENT CALLED TO REITERATE PROBLEMS OR CONCERNS AND PATIENT SAID "SHE WILL WORK WITH HER PRIMARY DOCTOR".
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8431059 ↗InjuryFeb 1, 2019Material Separation; Material Separation
IT WAS REPORTED THAT ON (B)(6) 2018, WHEN INSERTING A JELCO SAFETY PROTECTIV PLUS CATHETER A VENOUS RETURN WAS NOT OBSERVED. IT WAS OBSERVED THAT UPON REMOVAL A PART OF THE CATHETER REMAINED IN THE RIGHT FOREARM. A TOURNIQUET REMAINED AND IMMEDIATELY NOTIFIED THE DOCTOR. IT WAS REQUIRED THAT THE PATIENT WAS SENT TO PERFORM THE INSTITUTION'S MEDICAL PROTOCOL OF VENOUS EXTREMITIES STUDIES. NO FURTHER REPORTED ADVERSE EFFECTS.
Patient problems: Foreign Body In Patient
MAUDE report 8298733 ↗InjuryJan 23, 2019Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component
INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL JELCO PROTECTIV SAFETY I.V. CATHETER SEVERED IN A PATIENT AT THE HOSPITAL. THE PATIENT'S NURSE DISCONTINUED THE PATIENT'S WRIST IV AND IT WAS NOTICED THEN THAT THE CATHETER WAS NOT INTACT. AN ULTRASOUND WAS ABLE TO LOCATE THE MISSING PIECE. SUBSEQUENTLY, THE "PATIENT UNDERWENT AN INVASIVE PROCEDURE TO REMOVE THE PIECE FROM THEIR VEIN". NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 8271465 ↗MalfunctionDec 21, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL CATHETER WAS LEAKING. THE CANNULA HAD BROKEN OFF AND REMAINED IN PATIENT'S HAND.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8191541 ↗MalfunctionJun 12, 2018Product Quality Problem; Dull, Blunt; Product Quality Problem; Dull, Blunt
IT WAS REPORTED THAT THE JELCO SAFETY PROTECTIV PLUS CATHETER HAD A DULL NEEDLE. THE PATIENT HAD TO BE STUCK MULTIPLE TIMES FOR AN IV ATTEMPT. NO DEATH OR SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7594236 ↗
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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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