|
Model Number IPN917235 |
Device Problem
Material Split, Cut or Torn (4008)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/03/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
"it was reported that the lumen of the catheter for injecting contrast got torn during use, in spite that the contrast was being injected at the proper injection pressure.Therefore, the catheter was replaced with a new one and inserted at the same insertion site to complete the procedure.No harm to the patient was reported." patient status reported as "fine".
|
|
Event Description
|
"it was reported that the lumen of the catheter for injecting contrast got torn during use, in spite that the contrast was being injected at the proper injection pressure.Therefore, the catheter was replaced with a new one and inserted at the same insertion site to complete the procedure.No harm to the patient was reported." patient status reported as "fine".
|
|
Manufacturer Narrative
|
Qn#(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.
|
|
Search Alerts/Recalls
|
|
|