Catalog Number 324912 |
Device Problem
Break (1069)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/03/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
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 that 1 bd syringe 1.0ml 31ga 6mm cannula broke off.The following information was provided by the initial reporter : it was reported by the consumer that the needle broke off into the vial when attempting to draw insulin and was able to remove needle from vial.Date of event : (b)(6) 2021.Sample: yes.
|
|
Manufacturer Narrative
|
H6: investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.A review of the device history record was completed for batch# 1047957.All inspections were performed per the applicable operations qc specification.There were zero (0) notifications noted that did not pertain to the complaint.Bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.
|
|
Event Description
|
It was reported that 1 bd syringe 1.0ml 31ga 6mm cannula broke off.The following information was provided by the initial reporter: it was reported by the consumer that the needle broke off into the vial when attempting to draw insulin and was able to remove needle from vial.Date of event : (b)(6) 2021.Sample: yes.
|
|
Search Alerts/Recalls
|