inforMED
MalfunctionMQX

SEIRIN ACUPUNCTURE NEEDLE WITH GUIDE TUBE

Received Aug 2, 2023 · Event occurred Jul 11, 2023

Report MW5120522 · MDR key 17451811

Device

Generic name

Needle, Acupuncture, Single Use

Manufacturer

Seirin Corporation

Catalog number

11-0611

Lot number

21721H1

Patient

Unknown

  • Needle Stick/Puncture
  • Needle Stick/Puncture

Narrative

Description of Event or Problem

ACUPUNCTURE NEEDLES- SEIRIN NO.4 (.23)X30MM J-TYPE NEEDLE HAS NO SAFETY SHIELD WITH THE J-TYPE. WHEN YOU OPEN NEEDLE IT CAN AND HAS FALLEN OUT OF BOTTOM. AT TIMES IT HAS GONE THROUGH PLASTIC WHERE THE NEEDLE WILL STICK YOUR HAND. THE PINK PART THAT IS SUPPOSED TO HOLD THE NEEDLE DOES NOT GRIP IT TIGHT, ALLOWING THE NEEDLE TO SLIDE DOWN OUT OF THE SHEATH AND HAS GONE THROUGH THE PACKAGING CAUSING A NEEDLE STICK TO STAFF WHO WAS ATTEMPTING TO OPEN AND PRESENT THE NEEDLE TO THE PROVIDER FOR USE. THIS WAS A CLEAN NEEDLE STICK BUT STILL CAUSED STAFF INJURY. THE L-TYPE HAS A SHEATH OF A DIFFERENT COLOR AND MATERIAL THAT HOLDS THE ACUPUNCTURE NEEDLE AND THESE NEEDLES DO NOT SLIDE DOWN AND POSE A RISK.