Model Number 24630 |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 03/24/2020 |
Event Type
malfunction
|
Event Description
|
It was reported that there was foreign matter inside the sterile packaging.A 7.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.At the course of the procedure, it was noted that hair was found inside the sterile packaging.No patient complications were reported.
|
|
Manufacturer Narrative
|
Device evaluated by mfr: the device was returned for evaluation.The outer carton was opened.The inner pouch had also been opened.A visual examination identified foreign matter with the characteristics of a hair was inside the opened pouch.No other issues were identified during the product analysis.
|
|
Event Description
|
It was reported that there was foreign matter inside the sterile packaging.A 7.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.At the course of the procedure, it was noted that hair was found inside the sterile packaging.No patient complications were reported.
|
|
Search Alerts/Recalls
|