The reported event was unconfirmed, since the reported failure could not be reproduced.Visual evaluation of the returned sample noted one opened (no original packaging present), bulb evacuator.Concomitant, in-house evacuator tubing was the bulb evacuator.The other end of the tubing was placed in a reservoir of water.The empty port was opened and the bulb was squeezed.The port was then closed and the bulb released to suction water.The device suctioned 100cc of water as intended.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿11.To establish suction: 11.I.) open empty port.11.Ii.) squeeze evacuator.11.Iii.) close empty port.Note: reflux of fluid to the patient is minimized during reactivation by an anti-reflux valve in inlet port.12.To empty container: 12.I.) open empty port over collection basin.12.Ii.) squeeze evacuator to empty.13.To re-establish suction: repeat step 11 above.14.To read fluid volume: 14.I.) invert unit.14.Ii.) open empty port to release vacuum.14.Iii.) read and record approximate volume.14.Iv.) empty and reactivate evacuator.Important: a.Check for fluid entering closed wound suction evacuator.Lack of flow may indicate all exudate has been removed.B.When not using auxiliary suction during surgical wound closure, several activations of the closed wound suction evacuator may be required to establish suction because of the following: i.Air entering partially closed wound.Ii.An operative air pocket.C.The attached strap may be used to secure the evacuator to the patient." section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
|