Catalog Number CS-15703 |
Device Problems
Unraveled Material (1664); Physical Resistance/Sticking (4012)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 01/11/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
Qn#: (b)(4).Associated mdr#: 9680794-2023-00165.
|
|
Event Description
|
The complaint is reported as: "doctor reports that when placing the central venous catheter, after inserting the guide in the needle, it bents, when wanting to reposition it begins stucking, it is withdrawn and observes that a part of it loses its shape and rigidity similar to a rope that unthreads, running risk of rupture in the vascular area, is discarded by requesting a new equipment and the same happens" the catheter was replaced.Additional information was requested but was not available at the time of this report.
|
|
Event Description
|
The complaint is reported as: "doctor reports that when placing the central venous catheter, after inserting the guide in the needle, it bents, when wanting to reposition it begins stucking, it is withdrawn and observes that a part of it loses its shape and rigidity similar to a rope that unthreads, running risk of rupture in the vascular area, is discarded by requesting a new equipment and the same happens" the catheter was replaced.Additional information was requested but was not available at the time of this report.
|
|
Manufacturer Narrative
|
(b)(4).Associated mdr#s 9680794-2023-00222 and 9680794-2023-00165.Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.
|
|
Search Alerts/Recalls
|