SHANGHAI MEKON MEDICAL DEVICES CO., LTD.
Received Feb 27, 2025
Report 3003560965-2025-00004 · MDR key 21477216
Device
Generic name
Quincke Spinal Needle
Manufacturer
Zhejiang Kindly Medical Devices Co.,ltdModel number
22G*3.5" 22G*90MMLot number
20240930
Product problems
- Difficult or Delayed Separation
- Difficult or Delayed Separation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(1) RESIDUAL SAMPLE TEST: ON (B)(6) 2025, 10 ANAESTHESIA NEEDLES PRODUCTS WITH BATCH NUMBER: 20240930 SPECIFICATIONS: 22G3.5" 22G*90MM WERE SAMPLED AND TESTED AS FOLLOWS: A. FIVE ANAESTHESIA NEEDLES PRODUCTS WERE SELECTED FOR THE APPEARANCE INSPECTION OF THE NEEDLE HUB, AND NO ABNORMAL PHENOMENA OF BURR AND IRREGULARITY WERE FOUND. THE ABOVE FIVE PRODUCTS COULD BE REMOVED BY NORMAL OPERATION THROUGH SIMULATING THE CLINICAL REMOVAL CORE NEEDLE TEST. FOR DETAILS, SEE THE VIDEO OF SIMULATED CLINICAL OPENING TEST IN ANNEX 1. B. PULL OUT FORCE TEST WAS CARRIED OUT WITH THE NEEDLE HUB OF 5 ANESTHESIA NEEDLE PRODUCTS, THE PULL-OUT FORCE VALUE WAS 2.01N-2.98N, AND THE AVERAGE TEST RESULT WAS 2.412N. FOR DETAILS, PLEASE REFER TO THE TEST DRAWINGS AND DATA IN ANNEX 2. (2) CAUSE ANALYSIS: NO ABNORMALITY WAS FOUND TO BE DIFFICULT TO UNLOAD THROUGH THE ABOVE RESIDUAL SAMPLE DETECTION.
Description of Event or Problem
THE STYLET HAS A LITTLE CLIP-ON IT WHICH TAKES FORCE TO REMOVE AND DOES NOT REMOVE WITH EASE WHEN DOING PROCEDURES.