Catalog Number 320440 |
Device Problems
Detachment Of Device Component (1104); Entrapment of Device (1212)
|
Patient Problem
Foreign Body In Patient (2687)
|
Event Date 01/11/2018 |
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 the bd insulin syringe with the bd ultra-fine¿ needle separated and the needle remained in the skin.An x-ray was performed and the needle was removed from the skin with no surgical intervention required.
|
|
Manufacturer Narrative
|
Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.If samples are received in the future the complaint will be reopened for further investigation.Unable to perform dhr check due to unknown lot number for needle break off in use.Severity: s_3__; occurrence: unable to perform complaint lot history check due to unknown lot number for needle break off in use.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.Based on the above, no additional investigation and no capa is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
|
|
Search Alerts/Recalls
|