Catalog Number 1003327 |
Device Problems
Leak/Splash (1354); Loose or Intermittent Connection (1371)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/30/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that the indeflator device was attempted to be used in procedure to inflate a balloon; however, a leak was noted at the connection point.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.
|
|
Manufacturer Narrative
|
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.Na.
|
|
Manufacturer Narrative
|
The device was returned for analysis.The reported leak and loose / intermittent connection was unable to be confirmed.Device history record (dhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot level product quality issue.As the reported difficulties were unable to be confirmed during return analysis, it is possible that the devices were not properly aligned and/or not fully connected/tightened while attempting to connect and/or the port of the device being connected was compromised resulting in the reported loose/intermittent connection and ultimately resulting in the reported leak; however this cannot be confirmed.The investigation was unable to determine a conclusive cause for the reported difficulties.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
|
|
Event Description
|
Subsequent to the initial report being filed, returned device analysis testing found after multiple tests no leak was found and the rotator end of the indeflator formed a secure connection with no anomalies noted.No additional information was provided.
|
|
Search Alerts/Recalls
|