inforMED
MalfunctionQOI

MCKESSON BRANDS

Received Dec 4, 2025 · Event occurred Nov 21, 2025

Report 1451040-2025-00116 · MDR key 23719643

Device

Generic name

Cath, Iv Sfty Str Push Button Bc Pnk 20gx1"

Catalog number

200-IVRB201

Lot number

40576-0360

Product problems

  • Leak/Splash
  • Fail-Safe Problem
  • Leak/Splash
  • Fail-Safe Problem

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED BY THE CUSTOMER THAT CATHETER APPEARS TO BE OCCLUDED CAUSING FORCE TO BE USED TO PUSH THE PLUNGER. THIS RESULTS IN LEAKAGE DUE TO THE PRESSURE USED. THE CUSTOMER ALSO REPORTED THAT THE NEEDLE DOESN'T RETRACT AFTER PUSHING THE BUTTON. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THIS PRODUCT ISSUE.