VENTRICLEAR COOK CATHETER EVD 5 PK
Received Nov 2, 2020 · Event occurred Jun 17, 2020
Report 2021898-2020-00276 · MDR key 10774870
Device
Generic name
Catheter, Ventricular (containing Antibiotic Or Antimicrobial Agents)
Manufacturer
Medtronic NeurosurgeryModel number
NVVDC01ABRMCatalog number
NVVDC01ABRM
Lot number
UNKNOWN
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
IT WAS REPORTED THAT THE DOCTOR FELT THAT THE PRODUCT HAD CHANGED IN THE LAST COUPLE OF MONTHS. THERE HAD BEEN LEAKING OF CEREBROSPINAL FLUID AROUND THE CATHETER WHERE THE STITCHES ARE PLACED. THEY ALSO NOTED THAT IT FELT LIKE A NEW SOFTER MATERIAL. ADDITIONAL INFORMATION RECEIVED REPORTING THAT THE LEAK WAS FROM THE SKIN EXIT SITE AND HAD NOTHING TO DO WITH THE CONNECTIONS.