Model Number 382544 |
Device Problems
Backflow (1064); Leak/Splash (1354)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/04/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
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 while using a bd insyte¿ autoguard¿ bc shielded iv catheter, the blood control feature did not work and leakage occurred.The following information was provided by the initial reporter; 18g blood blew out at the end of the cath while starting the iv.
|
|
Manufacturer Narrative
|
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2022-feb-16.H6: investigation summary our quality engineer inspected the representative samples submitted for evaluation.Bd received three unopened units from lot number 0045346.The devices were inspected visually for any signs of damage, spear throughs, or oddities to the catheter tubing.The devices were also checked to see if the actuator was in the correct position.No defects were found.The devices then underwent testing for leakage beyond the septum.Leakage did not occur.Lastly the devices were leak tested.This will ensure no damage resulting in leakage was observed and a secure connection can be made.No leakage occurred.There was no physical/mechanical evidence to confirm and support a manufacturing process related issue for the failure stated in your report.The returned representative units provided for evaluation met and performed per the required manufacturing specifications.A device history record review showed no non-conformances associated with this issue during the production of this batch.
|
|
Event Description
|
It was reported that while using a bd insyte¿ autoguard¿ bc shielded iv catheter, the blood control feature did not work and leakage occurred.The following information was provided by the initial reporter; 18g blood blew out at the end of the cath while starting the iv.
|
|
Search Alerts/Recalls
|