Catalog Number CA-02220 |
Device Problem
Detachment Of Device Component (1104)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 04/03/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).The device has not been returned for investigation at this time.Teleflex will continue to monitor and trend related events.
|
|
Event Description
|
The filter and black and blue connectors come apart spontaneously during use.The product was attached by a physician, and checked hourly.At one of the hourly checks, the tubing and filter had come apart.The catheter was removed and replaced.
|
|
Manufacturer Narrative
|
(b)(4).A device history record review was performed on the flat filter and snaplock adapter with no relevant findings.A corrective action is not required at this time as a potential cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the flat filter and snaplock adapter with no relevant findings.Therefore, the potential cause of the filter disconnecting from the snaplock adapter could not be determined based upon the information provided and without a sample.
|
|
Event Description
|
The filter and black and blue connectors come apart spontaneously during use.The product was attached by a physician, and checked hourly.At one of the hourly checks, the tubing and filter had come apart.The catheter was removed and replaced.
|
|
Search Alerts/Recalls
|