MalfunctionGBW
OPEN-ENDED PERITONEAL CATHETER WITH SLITS, 120CM
Received Feb 10, 2014
Report 2648988-2014-00006 · MDR key 3832322
Device
Product problems
- Device Contamination with Chemical or Other Material
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.
Description of Event or Problem
IT WAS REPORTED THAT AN OPEN-ENDED PERITONEAL CATHETER WITH THE SLITS HAD BLACK "DIRT" ADHERED AT THE TIP OF THE CATHETER. THE ISSUE WAS FOUND UPON INCOMING INSPECTION.