Model Number 2426-0500 |
Device Problem
Hole In Material (1293)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 06/11/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.
|
|
Event Description
|
The customer reported noticing a hole 3 inches above the distal injection port of the tubing while infusing ns to a patient.The infusion was stopped while a replacement set was obtained.There was no patient harm.
|
|
Event Description
|
The customer reported noticing a hole 3 inches above the distal injection port of the tubing while infusing ns to a patient.The infusion was stopped while a replacement set was obtained.There was no patient harm.
|
|
Manufacturer Narrative
|
The customer¿s report of a hole in the tubing was confirmed.Visual inspection showed that the pvc tubing had a slice cut 3 inches above the distal smartsite inlet port.Functional and pressure testing confirmed leaking from the cut.The cause of the hole in the tubing was identified as a slice cut in the tubing consistent with damage from a sharp object.
|
|
Search Alerts/Recalls
|