Catalog Number ASK-05401-NM |
Device Problem
Break (1069)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 05/01/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
|
|
Event Description
|
It was reported that the kit contained broken vials of medication.
|
|
Manufacturer Narrative
|
(b)(4).A device history record review was performed with a potentially relevant finding.A nonconformance was initiated only as a general nonconformance to temporarily allow certain finished good part numbers to be packaged with additional gauze in order to better secure medication ampules in the inner tray.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed with a potentially relevant finding.Based on the information provided, the potential root cause of this issue is design related.A capa was initiated to further investigate this complaint issue.
|
|
Event Description
|
It was reported that the kit contained broken vials of medication.
|
|
Search Alerts/Recalls
|