Model Number IPN000074 |
Device Problem
Material Puncture/Hole (1504)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/29/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Qn# (b)(4).
|
|
Event Description
|
It was reported that a leak was found from the catheter during use on a patient.As a result, the catheter was replaced with a new kit.There was no report of patient complication, serious injury or death.
|
|
Event Description
|
It was reported that a leak was found from the catheter during use on a patient.As a result, the catheter was replaced with a new kit.There was no report of patient complication, serious injury or death.
|
|
Manufacturer Narrative
|
Qn#: (b)(4).The product was not returned for investigation.The reported complaint that a "leak was found from the catheter during use on a patient" is not able to be confirmed.If the product is returned at a later date, a full investigation of the sample will be completed.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.
|
|
Search Alerts/Recalls
|