MalfunctionHHT
PURITAN HISTOBRUSH
Received Jun 21, 2016 · Event occurred Apr 4, 2016
Report 1216735-2016-00002 · MDR key 5738558
Device
Generic name
Cytology Brush
Manufacturer
Puritan Medical Products Company LlcModel number
2199Catalog number
2199
Lot number
18636
Product problems
- Loss of or Failure to Bond
- Loss of or Failure to Bond
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
WE HAVE A 5-YEAR MARKET HISTORY OF (B)(4) CYTOLOGY DEVICES PER YEAR. THIS IS THE FIRST REPORT OF A BRUSH FAILURE. THE PRODUCTION RECORDS AND RESERVE SAMPLES FROM THE LOT WERE NORMAL. THIS REPORT IS ENTERED IN OUR TREND ANALYSIS PROGRAM AND WILL BE MONITORED FOR SIMILAR CLAIMS.
Description of Event or Problem
THE CUSTOMER REPORTS THAT THE END OF THE CYTOLOGY BRUSH CAME OFF DURING A PAP SMEAR PROCEDURE. THE DOCTOR RETRIEVED THE BRUSH.