Model Number 381434 |
Device Problem
Retraction Problem (1536)
|
Patient Problem
Needle Stick/Puncture (2462)
|
Event Date 01/26/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
Date of event: unknown.The date received by manufacturer has been used for this field.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 insyte¿ autoguard¿ shielded iv catheter needle would not retract and a dirty needle stick occurred as a result.No further information was provided.The following information was provided by the initial reporter: "needle is not retracting when button is pressed.Was there any patient impact? if so was there any need for medical treatment or intervention? there was staff impact as well as a needle stick.".
|
|
Event Description
|
It was reported that the bd insyte¿ autoguard¿ shielded iv catheter needle would not retract and a dirty needle stick occurred as a result.No further information was provided.The following information was provided by the initial reporter: "needle is not retracting when button is pressed.Was there any patient impact? if so was there any need for medical treatment or intervention? there was staff impact as well as a needle stick".
|
|
Manufacturer Narrative
|
H6: investigation summary : since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.However, a trend has been identified for the reported failure and corrective actions have been initiated to investigate this type of incident and identity the root cause.H3 other text : see h10.
|
|
Search Alerts/Recalls
|