The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The information provided by bard 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 bard.
|
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The information provided by bard 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 bard.
|
Received 1 used silicone channel drain only.Visual inspection noted no obvious defects.A functional evaluation was performed via a suction test.The device was connected to a 100cc evacuator.No suction was detected as water did not pass through the tube and drain channels.The drain was dissected from the connector-drain bonding for evaluation under 10 x magnification and occlusion with adhesive between the drain and connector was found.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The complaint was confirmed as a manufacturing related issue.The instructions for use state the following: "warnings: an effective closed suction drain system requires maintenance of the system to preserve patency.The drain must not be allowed to occlude nor the reservoir to completely fill; and reservoir suction must be maintained in order for the system to function properly.Verify that the system is functioning properly.If the system is not maintained properly, surgical complications, including hematomas, may result.In the event of occlusion of the drain, all wound drainage via the drain ceases.Careful attention to the drain will minimize the possibility of this problem.If occlusion does occur, the drain can be aspirated by connecting suction to the reservoir outlet or temporarily disconnecting the drain from the reservoir and applying suction directly to the drain.If an air-tight seal between the drain and the skin where the drain emerges is not achieved, the air leak must be rectified or the system must be converted to open drainage.An airtight seal between all system components (drain, adaptor and reservoir) is necessary for proper system function.The advantages of wound drainage, particularly closed system drainage, are lost if an air-tight seal between the drain and the skin where the drain emerges is not achieved, or if the drain is allowed to become occluded or if the reservoir is not activated properly, doesn¿t function properly or is not monitored.Evacuators should be emptied and re-activated when required per hospital protocol.In the event an air-tight seal is not achieved, the reservoir will rapidly fill with air from the leak; subsequent drainage to the reservoir will occur only if allowed by gravity and wound exudate forcing the flow.Entry into the reservoir is allowed only by displacement of air in the reservoir by wound exudate flow.In this is placement process, air reflux from the reservoir to the wound can occur and increase the likelihood of back-contamination across the anti-reflux valve.In the event of drain occlusion by fibrin, clots, or other particulate matter, all wound drainage via the drain ceases.If the reservoir is not emptied when it is full, equilibrium between the drain and reservoir at wound pressure will ultimately occur and drainage from the wound site will cease." the information provided by bard 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 bard.
|