Model Number 324911 |
Device Problem
Material Separation (1562)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/04/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
|
|
Event Description
|
It was reported while using bd veo insulin syringes with bd ultra-fine needle that needle hub separated on 3 syringes.The following information was provided by the initial reporter: consumer reported needle hub separation.Consumer reported 3 syringes affected.
|
|
Manufacturer Narrative
|
H.6.Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 1228510.All inspections were performed per the applicable operations qc specification.There were zero (0) notifications noted that pertained to the complaint.H3 other text : see h.10.
|
|
Event Description
|
It was reported while using bd veo insulin syringes with bd ultra-fine needle that needle hub separated on 3 syringes.The following information was provided by the initial reporter: consumer reported needle hub separation.Consumer reported 3 syringes affected.
|
|
Search Alerts/Recalls
|