Catalog Number 381433 |
Device Problem
Retraction Problem (1536)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/01/2024 |
Event Type
malfunction
|
Event Description
|
It was reported that bd insyte autoguard needle did not retract.The following information was provided by the initial reporter: customer reported incident where the needle has failed to retract.Comments on (b)(6) 2024.They reported incidents did happen during patient use, there were no injuries as a result of the failures.
|
|
Manufacturer Narrative
|
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.E1.Address information was not provided, therefore, xx was used as a place holder.
|
|
Manufacturer Narrative
|
Investigation results: a device history record review showed no non-conformances associated with this issue during the production of this batch.However, a trend has been identified for the reported failure and corrective actions have been initiated to investigate this type of incident and identity the root cause.Complaints received for this device and reported condition will continue to be tracked and trended.
|
|
Event Description
|
No additional information.
|
|
Search Alerts/Recalls
|