MalfunctionMBP
DBP PUTTY 5CC
Received Jan 7, 2013
Report 2090010-2012-00015 · MDR key 2906910
Device
Product problems
- Device Contamination with Chemical or Other Material
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PRODUCT HAS BLACK PARTICLES IN IT. THE DEVICE WAS NOT IN CONTACT WITH THE PATIENT. THERE WAS NO PATIENT INJURY/DEATH. THE CLINICIAN REPORTED THE PRODUCT WAS STORED PER LABELED INSTRUCTIONS AND ALL THE SEALS WERE INTACT PRIOR TO ATTEMPTED USE.
Additional Manufacturer Narrative
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.