Model Number 328438 |
Device Problems
Material Puncture/Hole (1504); Material Protrusion/Extrusion (2979)
|
Patient Problem
Needle Stick/Puncture (2462)
|
Event Date 09/02/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
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 fda device problem code(s): 2979, 1504.Fda patient problem code(s): 2462.
|
|
Event Description
|
It was reported that an unspecified number of bd insulin syringe with bd ultra-fine¿ needle experienced product damage while still considered operable during use.The product defect resulted in a needle stick injury to the device operator.It has not been specified whether any medical intervention/testing was administered as a result.The following information was provided by the initial reporter: material no: 328438 batch no: unknown (provided 0041302) after administering epoetin alfa on another individual i went to replace the orange cap on the needle.The tip of the needle went through the orange cap and pricked my finger.
|
|
Manufacturer Narrative
|
H.6.Investigation: no samples were returned as of 19 october 2020 therefore the investigation was performed based on the photos provided.Four (4) photos of a 0.3ml syringe were provided.Consumer reported went to replace the orange cap on the needle, and the tip of the needle went through the orange cap and pricked my finger.The provided photos were reviewed, and it was observed that the cannula on a used syringe had pierced through the cannula shield.No evidence of manufacturing defect could be determined from the photos provided.Since the syringe was captured after use, and no manufacturing defects were observed, the probable cause of the cannula through shield is user error: if the user removes or reattaches the cannula shield obliquely they may bend the cannula and potentially cause the cannula to pierce the shield.Unable to perform complaint a dhr review for cannula through shield and needle stick (after use) due to unknown lot number.
|
|
Event Description
|
It was reported that an unspecified number of bd insulin syringe with bd ultra-fine¿ needle experienced product damage while still considered operable during use.The product defect resulted in a needle stick injury to the device operator.It has not been specified whether any medical intervention/testing was administered as a result.The following information was provided by the initial reporter: material no: 328438 batch no: unknown (provided 0041302).After administering epoetin alfa on another individual i went to replace the orange cap on the needle.The tip of the needle went through the orange cap and pricked my finger.
|
|
Search Alerts/Recalls
|