Catalog Number 326702 |
Device Problem
Material Protrusion/Extrusion (2979)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/30/2022 |
Event Type
malfunction
|
Event Description
|
It was reported that the bd insulin syringe with bd ultra-fine¿ needle had a molding defect with a barbed needle.The following information was provided by the initial reporter: the needle is barbed.
|
|
Manufacturer Narrative
|
Date of event: unknown.Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
|
|
Event Description
|
It was reported that the bd insulin syringe with bd ultra-fine¿ needle had a molding defect with a barbed needle.The following information was provided by the initial reporter: the needle is barbed.
|
|
Manufacturer Narrative
|
The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: investigation summary: customer returned an image of a 1ml syringe.The needle hub of the syringe has a section of the flange broken away from the side of the hub, though it remains attached to it by a remaining thin strand of material.There was no burr to the needle itself.Due to the batch being unknown, no dhr review can be completed.Based on the samples received, embecta found that the needle hub was damaged.Root cause cannot be determined at this time as the issue is unconfirmed.
|
|
Search Alerts/Recalls
|