MalfunctionQOI
MCKESSON BRANDS
Received Dec 4, 2025 · Event occurred Nov 21, 2025
Report 1451040-2025-00117 · MDR key 23719814
Device
Generic name
Cath, Iv Sfty Str Push Button Bc Blu 22gx1"
Manufacturer
Harsoria HealthcareCatalog number
200-IVRB221
Lot number
50311/0212
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 THE 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 OTHER INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THIS PRODUCT ISSUE.