Catalog Number ASK-01618-PH |
Device Problem
Product Quality Problem (1506)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/11/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
Customer opened kit and found there to be an extra catheter of one size and no catheter of the other size.Customer did not specify what size was duplicated or missing.She then had to opened a second kit and found the same issue.The third kit was fine.Associated to 9680794-2024-00032.
|
|
Manufacturer Narrative
|
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number taken from the sales history data of the customer.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
|
Customer opened kit and found there to be an extra catheter of one size and no catheter of the other size.Customer did not specify what size was duplicated or missing.She then had to opened a second kit and found the same issue.The third kit was fine.Associated to 9680794-2024-00032.
|
|
Search Alerts/Recalls
|