Model Number 381834 |
Device Problem
Delivered as Unsterile Product (1421)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/15/2022 |
Event Type
malfunction
|
Event Description
|
It was reported that the bd insyte¿ autoguard¿ shielded iv catheter had a needle detach.The following information was provided by the initial reporter: when uncovering the insyte, the needle is observed inside the safety cap.When uncovering the catheter, the needle comes out along with the protector.
|
|
Manufacturer Narrative
|
Investigation summary: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.The manufacturing facility has been notified of this incident and the findings.A review of the device history record was performed and no quality issues were found during production.
|
|
Manufacturer Narrative
|
Investigation summary there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.The manufacturing facility has been notified of this incident and the findings.A review of the device history record was performed and no quality issues were found during production.
|
|
Event Description
|
It was reported that the bd insyte¿ autoguard¿ shielded iv catheter had a needle detach.The following information was provided by the initial reporter: when uncovering the insyte, the needle is observed inside the safety cap.When uncovering the catheter, the needle comes out along with the protector.
|
|
Search Alerts/Recalls
|