Catalog Number AK-01000 |
Device Problems
Fitting Problem (2183); Material Deformation (2976)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 03/27/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Potential lot number - 13f16l0141.
|
|
Event Description
|
The customer alleges that there is a problem with the luer connector on the drainage tube.The luer connector is partially flattened/squashed so it won't fit into the aspirating syringe and causing the procedure to take longer than usual.No patient injury or consequence.
|
|
Manufacturer Narrative
|
(b)(4).The event described in this complaint was deemed to be a non-reportable event; thus, the initial mdr that was submitted on 04/04/2017, was sent in error.
|
|
Event Description
|
The customer alleges that there is a problem with the luer connector on the drainage tube.The luer connector is partially flattened/squashed so it won't fit into the aspirating syringe and causing the procedure to take longer than usual.No patient injury or consequence.
|
|
Search Alerts/Recalls
|