Catalog Number 381023 |
Device Problem
Retraction Problem (1536)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/21/2024 |
Event Type
malfunction
|
Event Description
|
It was reported that bd iag bc pro global needle did not retract.The following information was provided by the initial reporter: one of our departments has come across this insyte that has a problems activating the retractable needle.They press on the white button and the needle doesn¿t retracted.
|
|
Manufacturer Narrative
|
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
|
|
Event Description
|
No additional information.
|
|
Manufacturer Narrative
|
Investigation results: the complaint that the retractable needle could not be activated was not confirmed.One photograph and seven 22g insyte autoguard units from lot #3360115 were provided for investigation.A visual and functional test of the returned samples revealed no damage or defects.Although the returned samples and manufacturing records do not support the complainant¿s description of the reported event, the complaint has been documented and will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.
|
|
Search Alerts/Recalls
|