Catalog Number CS-15853 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
|
Patient Problem
Tissue Damage (2104)
|
Event Date 05/01/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
The customer reports experiencing a problem with the device.Tearing of the veins as the catheter was introduced, which caused the user to open additional set.
|
|
Manufacturer Narrative
|
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
|
|
Event Description
|
The customer reports experiencing a problem with the device.Tearing of the veins as the catheter was introduced, which caused the user to open additional set.
|
|
Search Alerts/Recalls
|