MalfunctionFHO
PNEUMO-MATIC INSUFFLATION NEEDLE, 14 GAUGE, 120MM
Received Apr 6, 2017 · Event occurred Apr 5, 2017
Report MW5068962 · MDR key 6471330
Device
Generic name
Veress Needle
Manufacturer
Cooper SurgicalModel number
900-200Catalog number
900-200
Lot number
208315
Product problems
- Fluid/Blood Leak
Patient
42 YR
- No Information
- No Information
Narrative
Description of Event or Problem
TWO COOPER SURGICAL, PNEUMO-MATIC INSUFFLATION NEEDLES, WERE OPENED AND TESTED WITH LEAKS AND DISCOVERED IN EACH'S INTEGRITY. SURGEON TESTS NEEDLE BY OCCLUSION PRIOR TO UTILIZING DEVICE. TWO "LIKE" DEVICES. BOTH PNEUMO-MATIC INSUFFLATION NEEDLE - 14 GAUGE/120MM). NEEDLE #1 LOT: 208315 WITH EXP DATE: 10/04/2019. NEEDLE #2 LOT 213729 WITH EXP. DATE: 01/03/2020.