InjuryFIE

NIPRO DULL FISTULA NEEDLE 15G

Received Sep 4, 2025 · Event occurred Aug 14, 2025

Report MW5175663 · MDR key 22968194

Device

Generic name

Needle, Fistula

Manufacturer

Nipro (thailand) Corporation Limited

Lot number

23J24A

Product problems

Material Puncture/Hole

Patient

NA · Unknown

Hemorrhage/Blood Loss/Bleeding
Hemorrhage/Blood Loss/Bleeding

Narrative

Description of Event or Problem

IT WAS REPORTED VIA EMAIL THAT A PATIENT DISCOVERED A HOLE IN TUBING OF NEEDLE HUB. RESULTED IN APPROX. 100CC BLOOD LOSS AND DISCONTINUATION OF TREATMENT. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).