Catalog Number 328431 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Vitreous Floaters (1866)
|
Event Date 07/13/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
Medical device expiration date: unknown.Device manufacture date: unknown.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.Unable to perform dhr check due to unknown lot number.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.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.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Rationale: based on the investigation, no additional investigation and no capa is required at this time.
|
|
Event Description
|
It was reported "we¿ve been using insulin syringes for some intravitreal ocular injections.We¿ve recently seen an uptick in the number of floaters in the eye that we think may be caused by the silicone lubricant on the syringe and/or needle.We¿ve used these syringes for years without major issues, so we¿re wondering if the syringes have changed or if these may be caused by the products we¿re testing" this occurred with bd insulin syringe with bd ultra-fine¿ needle.No medical intervention was reported.
|
|
Event Description
|
It was reported "we¿ve been using insulin syringes for some intravitreal ocular injections.We¿ve recently seen an uptick in the number of floaters in the eye that we think may be caused by the silicone lubricant on the syringe and/or needle.We¿ve used these syringes for years without major issues, so we¿re wondering if the syringes have changed or if these may be caused by the products we¿re testing" this occurred with bd insulin syringe with bd ultra-fine¿ needle.No medical intervention was reported.
|
|
Manufacturer Narrative
|
Correction: due to an it issue beginning on 07/03/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other device single use?: no device returned to manufacture: no.
|
|
Search Alerts/Recalls
|