MalfunctionFHO
PNEUMO-MATIC INSUFFLATION NEEDLE
Received Oct 13, 2017 · Event occurred Oct 11, 2017
Report MW5072745 · MDR key 6947550
Device
Generic name
Veress Needle
Manufacturer
Cooper SurgicalModel number
900-200Catalog number
900-200
Lot number
225665
Product problems
- Leak/Splash
- Failure of Device to Self-Test
Patient
26 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
COOPER SURGICAL, PNEUMO-MATIC INSUFFLATION NEEDLES WOULD NOT PASS LEAK TEST PRIOR TO USE. TWO DIFFERENT LOT NUMBERS WERE NOTED FROM THE THREE DEVICES.