Catalog Number 305945 |
Device Problems
Device Operates Differently Than Expected (2913); Fail-Safe Problem (2936)
|
Patient Problem
Needle Stick/Puncture (2462)
|
Event Date 03/19/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
Medical device expiration date: unknown.Device manufacture date: unknown.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 multiple needle stick injuries have occurred while using bd¿ syringes with permanently attached safetyglide¿ needles because of difficulty with engaging the safety caps.There was no report of medical intervention.
|
|
Manufacturer Narrative
|
Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.A dhr check was not performed as the lot number is "unknown" for this complaint.Based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.
|
|
Search Alerts/Recalls
|