Catalog Number AK-05560 |
Device Problem
Physical Resistance (2578)
|
Patient Problem
No Information (3190)
|
Event Date 11/01/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).The device has not been returned for investigation at this time.The manufacturer will continue to monitor and trend related events.
|
|
Event Description
|
The loss of resistance syringe barrel is sticking in the syringe.The patient's condition was reported as unknown.
|
|
Manufacturer Narrative
|
(b)(4).No lot number was provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the lor syringe 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 based upon a lot number from sales history data.A device history record review was performed on the lor syringe with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of the lor syringe sticking could not be determined based upon the information provided and without a sample.
|
|
Event Description
|
The loss of resistance syringe barrel is sticking in the syringe.The patient's condition was reported as unknown.
|
|
Search Alerts/Recalls
|