BD BONNANO¿ SUPRAPUBIC CATHETER TRAY
Received Feb 23, 2017 · Event occurred Feb 9, 2017
Report 2618282-2017-00001 · MDR key 6355477
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Needle Stick/Puncture
- Needle Stick/Puncture
Narrative
Additional Manufacturer Narrative
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT A PHYSICIAN SUFFERED A CONTAMINATED NEEDLE STICK INJURY FROM AN 18 GAUGE NEEDLE IN A BD BONNANO SUPRAPUBIC CATHETER TRAY. THE PHYSICIAN FOLLOWED PROTOCOL FOR AN OCCUPATIONAL BLOOD EXPOSURE.