Jelco 306501Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10351688071163), received between Sep 11, 2017 and Feb 2, 2026 — classified as 4 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (5 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.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE NEEDLES WERE DULL, CAUSING MORE BLOWN SITES. BLOOD TRAVELED THROUGH THE ENTIRE SET IMMEDIATELY AFTER VEIN PUNCTURE. THE NEEDLE HAD TO BE RETRACTED VERY QUICKLY, OFTEN LEADING TO BLOWN SITES, AND BLOOD FREQUENTLY LEAKED FROM THE PORT ONTO THE PATIENT, BED, AND FLOOR WORSE THAN THE PROTECTIVE PLUS SERIES, WITH SOME APPLICATORS DISLODGING. THERE WAS A PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24235602 ↗
• MalfunctionMay 9, 2025Break; Break

  IT WAS REPORTED THAT THE CATHETER BROKE OFF AT THE INSERTION HUB INSIDE THE PATIENT AND WAS REMOVED FROM THE PATIENT. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994561 ↗
• MalfunctionJan 15, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE HEALTHCARE PROVIDER WAS UNABLE TO REMOVE THE NEEDLE FROM THE CATHETER DUE TO THE CATHETER STICKING UPON INSERTION. TO RESOLVE THE ISSUE, A 20G IV WAS USED DURING SYNCHRONIZED CARDIOVERSION. THE CUSTOMER STATES THAT THERE WAS MINIMAL/TEMPORARY HARM TO THE PATIENT. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21160052 ↗
• MalfunctionNov 12, 2024Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHEN PUNCTURING, THE SILICONE DEVICE WAS RELEASED AND BROKEN. THERE WAS PATIENT INVOLVEMENT HOWEVER THERE WAS NO HARM AS RESULT OF THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20663841 ↗
• MalfunctionNov 12, 2024Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHEN PUNCTURING, THE SILICONE DEVICE WAS RELEASED AND BROKEN. THERE WAS PATIENT INVOLVEMENT HOWEVER THERE WAS NO HARM AS RESULT OF THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20662983 ↗
• MalfunctionJul 2, 2024Positioning Failure; Fail-Safe Problem; Positioning Failure; Fail-Safe Problem

  IT WAS REPORTED THAT THE 18G IV CATHETER COULD NOT ADVANCE OR RETRACT THE NEEDLE INTO THE SAFETY CLOSURE. THERE WAS PATIENT INVOLVEMENT AND MINIMAL PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19660167 ↗
• MalfunctionJun 13, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER THE NURSE INSERTED THE CATHETER, BLOOD STARTED SPRAYING ON HER AND THE PATIENT. SHE REMOVED THE IV AND FOUND THE CATHETER TO BE BROKEN. THERE WAS PATIENT INVOLVEMENT AND PATIENT HARM REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19531254 ↗
• MalfunctionMay 1, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE DEVICE IS BLUNT AND DOES NOT PIERCE THE PATIENT' SKIN. IT TOOK SEVERAL PUNCTURES WERE NECESSARY TO GET IT RIGHT. NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 16850827 ↗
• MalfunctionApr 13, 2023Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT INSERTION OF THE 18G CATHETER INTO THE VEIN WAS DIFFICULT. THE INFUSION PRODUCTS BREACHED THE VEIN AND DIFFUSED ELSEWHERE. THIS REQUIRED MULTIPLE INSERTIONS WITH ALTERATION OF THE PERIPHERAL VENOUS CAPITAL. THERE HAS BEEN NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16737285 ↗
• MalfunctionApr 13, 2023Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT INSERTION OF THE 18G CATHETER INTO THE VEIN WAS DIFFICULT. THE INFUSION PRODUCTS BREACHED THE VEIN AND DIFFUSED ELSEWHERE. THIS REQUIRED MULTIPLE INSERTIONS WITH ALTERATION OF THE PERIPHERAL VENOUS CAPITAL. THERE HAS BEEN NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16737051 ↗
• MalfunctionApr 13, 2023Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT INSERTION OF THE 18G CATHETER INTO THE VEIN WAS DIFFICULT. THE INFUSION PRODUCTS BREACHED THE VEIN AND DIFFUSED ELSEWHERE. THIS REQUIRED MULTIPLE INSERTIONS WITH ALTERATION OF THE PERIPHERAL VENOUS CAPITAL. THERE HAS BEEN NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16736858 ↗
• MalfunctionMay 12, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT OCCASIONALLY THE CATHETER LOCKS TOO EARLY BEFORE THE ENTIRE NEEDLE IS WITHIN THE SHEATH. POLLING OUR PRACTITIONERS MANY OF THEM HAVE EXPERIENCED THIS AT ONE TIME OR ANOTHER. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14383401 ↗
• MalfunctionMay 12, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT OCCASIONALLY THE CATHETER LOCKS TOO EARLY BEFORE THE ENTIRE NEEDLE IS WITHIN THE SHEATH. POLLING OUR PRACTITIONERS MANY OF THEM HAVE EXPERIENCED THIS AT ONE TIME OR ANOTHER. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14383224 ↗
• MalfunctionMay 12, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT OCCASIONALLY THE CATHETER LOCKS TOO EARLY BEFORE THE ENTIRE NEEDLE IS WITHIN THE SHEATH. POLLING OUR PRACTITIONERS MANY OF THEM HAVE EXPERIENCED THIS AT ONE TIME OR ANOTHER. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14383201 ↗
• MalfunctionMay 4, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE NEEDLE WAS INSERTED INTO THE VEIN AND THE LOCK DID NOT ENGAGED. THE NEEDLE WAS LEFT EXPOSED AND DID NOT RETRACT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14283667 ↗
• MalfunctionApr 6, 2022Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT AFTER STARTING IV, SHARP NEEDLE DID NOT RETRACT. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14021403 ↗
• MalfunctionMay 7, 2021Fluid/Blood Leak; Defective Component; Fluid/Blood Leak; Defective Component

  DURING PUNCTURE, THE CATHETER INSERTION PROCEDURE REQUIRES THE SAFETY DEVICE TO SLIDE IN ITS ENTIRETY TO RETRACT THE NEEDLE, REQUIRING THE PROFESSIONAL TO USE BOTH HANDS IN THIS STEP TO RETRACT AND DISCONNECT THE DEVICE. INFORMATION WAS RECEIVED INDICATING THAT WHEN RELIEVING THE PRESSURE AT THE INSERTION SITE AN MAKING A DETACHMENT MANEUVER WITH A SMITHS MEDICAL JELCO SAFETY PROTECTIV PLUS PERIPHERAL INTRAVENOUS CATHETER, THERE WERE SITUATIONS OF BLOOD LEAKAGE AND LOSS OF PUNCTURES. THERE WAS NO REPORTED ADVERSE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 11793004 ↗
• InjuryJan 4, 2019Material Fragmentation; Material Fragmentation

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL CATHETER WAS STUCK IN THE PATIENT'S ARM. UPON REMOVAL, WAS MET WITH RESISTANCE AND A DEFECT OF THE PRODUCT WAS DESCRIBED AS " THE TIP OF THE CATHETER LOOKS BAD". THE IV SITE WAS NOTED TO BLEED SLIGHTLY MORE THAN NORMAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8219757 ↗
• InjuryDec 26, 2018Material Fragmentation; Material Fragmentation

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL CATHETER DID NOT FULLY THREAD INTO PATIENT. UPON REMOVAL, PART OF THE CATHETER HAD REMAINED IN THE PATIENT. THE MD COULD FEEL A SMALL SOFT SUBCUTANEOUS BUMP OVER THE LEFT EXTERNAL JUGULAR. RETRIEVAL OF THE FOREIGN BODY WAS COMPLETED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8197104 ↗
• MalfunctionJul 23, 2018Mechanical Jam; Mechanical Jam

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL JELCO PLUS CATHETER WAS NOTED TO BE DIFFICULT TO THREAD. STAFF WERE REQUIRED TO PULL THE NEEDLE OUT IN ORDER TO THREAD CATHETER INTO THE VEIN. NO PATIENT INJURY RESULTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7711117 ↗
• MalfunctionApr 10, 2018Device Contamination with Chemical or Other Material

  CHARGE RN REPORTED TO THIS WRITER THAT A HAIR WAS NOTED INSIDE THE SEALED PACKAGING OF AN IV CATHETER.

  Patient problems: No Information

  MAUDE report 7412103 ↗
• InjuryFeb 7, 2018Break; Break

  INFORMATION WAS RECEIVED INDICATING THAT DURING REMOVAL OF A (B)(6) MEDICAL JELCO PROTECTIV SAFETY I.V. CATHETER A PIECE BROKE OFF IN THE PATIENT'S RIGHT ANTECUBITAL. IT WAS REPORTED THAT DURING REMOVAL OF CATHETER, RESISTANCE WAS MET, BUT WAS CONTINUED TO BE PULLED, AND THE END BROKE OFF. AN X-RAY WAS PERFORMED AND NOTED THAT THE CATHETER PIECE WAS IN THE RIGHT ANTECUBITAL OF THE PATIENT'S ARM. A VASCULAR SURGEON WAS NOTIFIED, ANTIBIOTIC ORDERED AND THE PATIENT WAS SENT HOME. HOWEVER, THE PATIENT WAS SCHEDULED FOR SURGICAL REMOVAL THE FOLLOWING DAY. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7248395 ↗
• InjurySep 11, 2017Bent; Material Fragmentation; Bent; Material Fragmentation

  IT WAS REPORTED THAT UPON THE REMOVAL OF A JELCO® PROTECTIV® SAFETY I.V. CATHETER, A SMALL AREA OF THE CATHETER APPEARED TO BE MISSING. THE CATHETER WAS BENT AND THE TIP WAS BROKEN IN A "V" SHAPE. THE REMOVAL OF THE CATHETER HAPPENED IN A MEDICAL CENTER. IT WAS REPORTED THAT THE PATIENT HAD OTHER SERIOUS MEDICAL EVENT. IT WAS ALSO REPORTED THAT THERE WERE NO PLANS FOR FURTHER INTERVENTION AND THAT THE PATIENT WAS DISCHARGED FROM THE MEDICAL CENTER IN STABLE CONDITION. NO OTHER ADVERSE HEALTH OUTCOMES WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6856050 ↗