MalfunctionFHO
PNEUMO-MATIC INSUFFLATION NEEDLE
Received Nov 27, 2017 · Event occurred Nov 21, 2017
Report MW5073559 · MDR key 7058947
Device
Generic name
Varess Needle
Manufacturer
Cooper SurgicalModel number
900-200Catalog number
900-200
Lot number
225665
Product problems
- Failure of Device to Self-Test
Patient
40 YR
- No Information
- No Information
Narrative
Description of Event or Problem
COOPER SURGICAL, PNEUMO-MATIC INSUFFLATION NEEDLE (14 GAUGE), DID NOT PASS OCCLUSION TEST PRIOR TO USE. THE DEFECTIVE NEEDLE WAS REMOVED FROM THE FIELD AND EXCHANGED FOR ANOTHER "LIKE" PRODUCT THAT WORKED WITHOUT ISSUE.