Jelco 328600Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10351688081957), received between Sep 14, 2021 and Jul 7, 2026 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 2026Break

  IT WAS REPORTED THAT PATIENT HAD NAUSEA AND VOMITING AND HAD AN INTRAVENOUS (IV) PUT IN FOR BLOOD WORK AND MEDICATIONS. THE PATIENT THEN PRESENTED WITH REDNESS TO THE LEFT HAND WHERE IV HAD BEEN. TENDERNESS AND PAIN TO AREA. UPON INSPECTION, THERE WAS A SMALL AREA THAT WAS ROLLABLE AND PALPABLE CANNULA IN HAND. THE PHYSICIAN CUT INTO HAND AND PULLED OUT A SMALL 7CM TUBE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 25738724 ↗
• MalfunctionMay 26, 2026Retraction Problem

  IT WAS REPORTED THAT THE VIAP W 20G X 1 1/4 200/CA WAS INVOLVED IN AN EVENT WHERE A PRACTITIONER WAS INITIATING A 20G IV ON A PATIENT IN THE BACK OF AN AMBULANCE WHILE STILL ON SCENE. ONCE THE CATHETER WAS ADVANCED INTO THE VEIN, THE NEEDLE REPORTEDLY FAILED TO RETRACT PROPERLY AND LOCK INTO THE SAFETY CASING. DURING ATTEMPTS TO MANAGE THE IV(INTRA-VENOUS), THE BACK PLASTIC CHAMBER ON THE IV CASING BECAME DETACHED. AS A RESULT, BLOOD REPORTEDLY SPRAYED SEVERAL FEET FROM THE IV SITE AND SPILLED ONTO THE FLOOR IN FRONT OF THE PATIENT, WHO WAS SEATED IN THE AIRWAY CHAIR. LEAKING OF BLOOD FROM THE VIA VALVE CATHETER EXPOSED THE PATIENT AND HEALTH CARE PROFESSIONAL TO THE BLOOD BORNE PATHOGENS. THERE WAS PATIENT INVOLVEMENT, AND NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25279531 ↗
• MalfunctionNov 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE WHILE THE CATHETER WAS THREADED INTO THE VEIN, THE VALVE DID NOT WORK, AND BLOOD CAME OUT OF THE INTRAVENOUS. THERE WAS PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23513605 ↗
• MalfunctionSep 17, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE CATHETER EXHIBITED A BLOOD LEAKAGE AT THE HUB OF THE IV. THERE WAS PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23077157 ↗
• MalfunctionJun 24, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WITH THE DEVICE, PRIOR TO THE NEEDLE PROTRACTING INTO THE SAFETY CAGE, BLOOD BEGAN LEAKING OUT AND CONTINUED TO LEAK UNTIL THE SALINE LOCK WAS ATTACHED. BECAUSE IT WAS SO UNUSUAL FOR ALL THE LEAKING THEY INSPECTED THE HUB OF THE CATHETER IN SITU, AND NOTED THE PINK PLASTIC CATHLON WAS BROKEN OFF AT THE HUB, EXPOSING THE STEEL INSERT INSIDE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19596593 ↗
• InjuryMay 5, 2023Disconnection; Material Separation; Disconnection; Material Separation

  IT WAS REPORTED THAT WHILE USING A NUMBER 20 IV ON A PATIENT, THE NEEDLE RETRACTED CAUSING THE PINK HUB TO FALL TO THE FLOOR WITHOUT THE TUBING. THE CUSTOMER INSTANTLY APPLIED PRESSURE TO THE BLOOD VESSEL A FEW INCHES ABOVE THE INSERTION SITE, IN THE EVENT THAT THE PLASTIC TUBING WAS IN THE PATIENT'S ARM. CUSTOMER CALLED THE DR. OVER IMMEDIATELY TO DO AN ULTRASOUND OF THE ARM TO ENSURE THE PLASTIC TUBING WAS NOT IN THE PATIENT'S ARM FLOATING UNATTACHED. THERE WAS NO EVIDENCE OF THE TUBING ON THE ULTRASOUND OR XRAY. ON PALPATION, CUSTOMER COULDN'T FEEL ANY FOREIGN OBJECTS EITHER. THE MISSING PIECE WAS NEVER LOCATED. PATIENT IS FINE AS OF THIS MOMENT, AND IS AWARE TO NOTIFY STAFF IF THEY NOTICE ANY PAIN, OR SORENESS, SHORTNESS OF BREATH (SOB). NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16880136 ↗
• MalfunctionSep 14, 2021Break; Break

  INFORMATION WAS RECEIVED INDICATING THAT DURING THE INSERTION ATTEMPT OF A SMITHS MEDICAL PERIPHERAL INTRAVENOUS CATHETER(PIVC)/JELCO SAFETY VIAVALVE CATHETER INTO THE RIGHT ANTECUBITAL, THE NURSE NOTED THAT THE NEEDLE TIP BROKE OFF WHILE WITHDRAWING THE NEEDLE. IT WAS ALSO REPORTED THAT A FLASH OF BLOOD WAS NOTED AS WELL, SUBSEQUENTLY, THE NURSE WITHDREW CATHETER AND NEEDLE IMMEDIATELY. NO FURTHER ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12467485 ↗

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,