inforMED
MalfunctionJKA

VACUTAINER

Received Sep 22, 2022 · Event occurred Sep 18, 2022

Report MW5112239 · MDR key 15470806

Device

Generic name

Tubes, Vials, Systems, Serum Separators, Blood Collection

Catalog number

ES23515

Lot number

220504

Product problems

  • Detachment of Device or Device Component

Patient

Unknown

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

Narrative

Description of Event or Problem

THE AZOR ADAPTORS BECAME DETACHED WHILE PERFORMING A PHLEBOTOMY PROCEDURE. THIS IS OCCURRED WHILE USING THE BUTTERFLY NEEDLE. FDA SAFETY REPORT ID #(B)(4).