MalfunctionGDM
HAWKINS III FLEXSTRAND BLN
Received Nov 9, 2021 · Event occurred Oct 19, 2021
Report MW5105248 · MDR key 12787828
Device
Generic name
Needle, Aspiration And Injection, Reusable
Manufacturer
Argon Medical Devices, Inc.Model number
253100Catalog number
253100
Lot number
11381708
Product problems
- Material Twisted/Bent
Patient
66 YR · Female
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
TIP OF BEVEL OF HAWKINS NEEDLE BENT TIMES THREE DEVICES ALL FROM THE SAME LOT NUMBER. NONE WERE ABLE TO BE USED. FDA SAFETY REPORT ID# (B)(4).