Catalog Number 381434 |
Device Problem
Backflow (1064)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/11/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that the bd insyte¿ autoguard¿ shielded iv catheter experienced blood backflow.2 of 3 related files.The following information was provided by the initial reporter: issue 3 occurrences with 3 different pts of blood back flow.Customer to collect samples for evaluation.
|
|
Manufacturer Narrative
|
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
|
|
Manufacturer Narrative
|
H.6.Investigation summary: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.Examination of the actual product involved may provide clarification as to the cause for the reported failure.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
|
|
Event Description
|
It was reported that the bd insyte¿ autoguard¿ shielded iv catheter experienced blood backflow.2 of 3 related files.The following information was provided by the initial reporter: issue 3 occurrences with 3 different pts of blood back flow.Customer to collect samples for evaluation.
|
|
Search Alerts/Recalls
|