Jelco 328300Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10351688081971), received between May 14, 2022 and May 21, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K160235); they may or may not involve this specific model.

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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026Fluid/Blood Leak

  IT WAS REPORTED BY NURSING STAFF THAT THE PATIENTS IV INITIATED WITH 24G VIAVALVE CATHETER AS PER SITE POLICY. PACKAGING INTACT. AFTER INSERTION, THE PATIENT NOTICED BLOOD WAS LEAKING FROM IV HUB WHERE IT MEETS THE INSERTION SITE. FLUSHED THE IV WITH NS SYRINGE AND THE SALINE LEAKED AROUND INSERTION SITE. IV CATHETER REMOVED AND INSPECTED. NOTED THAT THERE WAS A SMALL LEAK WHERE CATHETER MEETS THE HUB. THERE WAS PATIENT INVOLVEMENT WITH NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25241329 ↗
• MalfunctionMay 13, 2026Obstruction of Flow

  AN EVENT INVOLVING A JELCO VIAVALVE IV CATHETER REPORTED THAT DURING THE SECOND INTRAVENOUS (IV) INSERTION ATTEMPT BY AN ADVANCED IV STARTER, THE IV DEVICE MALFUNCTIONED AFTER BLOOD RETURN WAS OBTAINED. THE NEEDLE AND A SMALL PLASTIC COMPONENT BECAME LODGED WITHIN THE IV HUB, PREVENTING USE OF THE IV FOR BLOODWORK OR FLUID ADMINISTRATION AND REQUIRING REMOVAL OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25161657 ↗
• MalfunctionJun 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT IV CANNULA IS SUPPOSED TO BE BLOOD LESS. THE FILTER IS NOT WORKING AS IV CANNULAS HAVE BEEN LEAKING. THERE WAS PATIENT INVOLVEMENT, AND NO HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19463841 ↗
• MalfunctionJun 4, 2024Burst Container or Vessel; Fluid/Blood Leak; Material Puncture/Hole; Burst Container or Vessel; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT IV CATHETER 24G WAS INSERTED INTO PATIENT AND CAUSED SIGNIFICANT PAIN. PATIENT STARTED BLEEDING FROM THE IV INSERTION SITE (POKE) WHILE IV CATHETER WAS IN. WHEN FLUSHED WITH NORMAL SALINE, IV BLEW. WHEN RN TOOK THE IV OUT AND LOOKED CLOSELY - THE IV HAD "RIDGES" LIKE EXTRA PLASTIC ON CATHETER AND A HOLE. PATIENT GOT A NEW IV INSERTED AND EVERYTHING WAS FINE. THERE WAS PATIENT INVOLVEMENT AND MINIMAL PATIENT HARM.

  Patient problems: Pain

  MAUDE report 19461211 ↗
• MalfunctionSep 6, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED WHEN STARTING IV'S IT WAS HARD TO BREAK THROUGH THE PATIENTS SKIN WITH THE NEEDLE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15362048 ↗
• MalfunctionMay 14, 2022Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  IT WAS REPORTED THAT THE SAFETY DID NOT ENGAGE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14403076 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160235. One submission often covers many models, so check the product and lot details in each record.

• Z-1218-2019 · Aug 22, 2018 · Terminated
  Jelco(R) ViaValve(TM) safety intravenous (I.V.) catheters, 18G x 1 1/4", Model Number REF 3265, MOD 10 The Jelco(R) ViaValve(TM) safety I.V. catheter is a sterile, non pyrogenic,