BARD ACCESS SYSTEMS POWER PORT MRI ISP, 8 FR CHRONOFLEX, INT WO SP, ATTACH SL; IMPLANTED PORT
|
Back to Search Results |
|
Catalog Number 8808061 |
Device Problems
Difficult to Remove (1528); Material Deformation (2976)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Type
malfunction
|
Manufacturer Narrative
|
As the lot number for the device was provided, a lot history review was performed.The sample was not returned to the manufacturer for evaluation.The investigation is inconclusive for difficult to remove and material deformation.A definitive root cause for the reported event could not be determined.The device is labeled for single use.
|
|
Event Description
|
This report summarizes one malfunction.A review of the reported information indicated that model 8808061 implanted port allegedly experienced difficult to remove and material deformation.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The patient age, sex and weight were not provided.
|
|
Search Alerts/Recalls
|
|
|