Catalog Number AK-05502 |
Device Problem
Break (1069)
|
Patient Problem
Not Applicable (3189)
|
Event Date 12/18/2018 |
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 there were broken ampules when opening package.There was no injury.
|
|
Manufacturer Narrative
|
Qn# (b)(4).A device history record review was performed with a potentially relevant finding.A non-conformance was initiated to address broken ampule issues for lot# 23f18k0548.The customer reported broken ampules in the kit.The customer returned one opened kit which contained the lidocaine ampule broken into two pieces for investigation.The ampule was visually examined with and without magnification.Visual examination of the ampule revealed the ampule is broken at the score line.No pieces of the ampule appear to be missing.No other defects or anomalies were observed.The reported complaint of broken ampules was confirmed based upon the sample received.The lidocaine ampule was found to have broken at the score line.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 non-conformance was initiated to further investigate this complaint issue.
|
|
Event Description
|
It was reported that there were broken ampules when opening package.There was no injury.
|
|
Search Alerts/Recalls
|