MalfunctionBSP

MCKESSON BRANDS

Received Jun 25, 2024 · Event occurred May 31, 2024

Report 1451040-2024-00031 · MDR key 19605155

Device

Generic name

Needle, Spinal Quincke 22gx3.5

Manufacturer

Hanaco Medical Co., Ltd.

Catalog number

4631V2

Lot number

2207064

Product problems

Crack
Leak/Splash
Crack
Leak/Splash

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 ON EIGHT OCCASIONS, THE SPINAL NEEDLES CRACKED IN THE VIEW WINDOW AND ON THE LURE. THE CRACKING HAPPENED DURING ADMINISTRATION AND SMALL AMOUNTS OF ANESTHETIC WERE LOST DUE TO THE ISSUE. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THIS REPORTED ISSUE.