Jelco 338300Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10351688071569), received between Dec 5, 2020 and Sep 10, 2022 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K012128); 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2022Break; Break

  IT WAS REPORTED THAT THE CATHETER SHEARED DURING INSERTION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397527 ↗
• MalfunctionSep 9, 2022Break; Break

  IT WAS REPORTED THAT THE CATHETER SHEARED DURING INSERTION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397440 ↗
• MalfunctionSep 9, 2022Break; Break

  IT WAS REPORTED THAT THE CATHETER SHEARED DURING INSERTION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397425 ↗
• InjurySep 15, 2021Break; Break

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PERIPHERAL INTRAVENOUS CATHETERS (PIVC)/JELCO SAFETY ACUVANCE CATHETER, WAS PARTIALLY SHEARED OFF IN THE BABY'S HAND AND WAS REMOVED AT BEDSIDE. IT WAS REPORTED THAT IMAGING WAS PERFORMED TO CONFIRM CATHETER WAS FULLY REMOVED. NO FURTHER EVENTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12476364 ↗
• MalfunctionFeb 18, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE NEEDLE WOULD NOT SEPARATE FROM THE CATHETER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11341542 ↗
• MalfunctionDec 5, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE NEONATAL INTENSIVE CARE UNIT (NICU) NURSE WAS UNABLE TO PLACE THE CATHETER ON THE PREMATURE INFANT. NO ONWARD PATIENT EFFECTS WERE REPORTED. AN I.V CATHETER FROM AN ALTERNATIVE VENDOR WAS USED ON THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10951305 ↗
• MalfunctionDec 5, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE NEONATAL INTENSIVE CARE UNIT (NICU) NURSE WAS UNABLE TO PLACE THE CATHETER ON THE PREMATURE INFANT. NO ONTWARD PATIENT EFFECTS WERE REPORTED. AN I.V CATHETER FROM AN ALTERNATIVE VENDOR WAS USED ON THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10951222 ↗
• MalfunctionDec 5, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE NEONATAL INTENSIVE CARE UNIT (NICU) NURSE WAS UNABLE TO PLACE THE CATHETER ON THE PREMATURE INFANT. NO ONTWARD PATIENT EFFECTS WERE REPORTED. AN I.V CATHETER FROM AN ALTERNATIVE VENDOR WAS USED ON THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10951117 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K012128. One submission often covers many models, so check the product and lot details in each record.

• Z-0789-2017 · Nov 21, 2016 · Terminated
  Acuvance2 Safety Catheter, Product No. 1720-AI Product Usage: The Acuvance 2 Safety Catheter is a Peripheral Intravenous Catheter (PIVC). PIVCs are designed for single use venipun