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.
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Received 1 round drain for evaluation.The reported event was unconfirmed as the problem could not be reproduced.The visual inspection noted no obvious defects in the sample received.A suction test was performed during the functional evaluation.The drain was connected to the inlet port of the evacuator and the drain end was submerged in water.The evacuator was compressed and rolled over, which was kept compressed by hand.The outlet port was then closed.The evacuator suctioned 100cc of water without any difficulties.In addition, it was noted that the evacuator recovered its original shape once it suctioned.The drain suctioned 100 cc of water with no problems.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: "indications: bard channel drains, round and flat silicone, are indicated for use with selected bard evacuators for closed wound drainage following head and neck, orthopedic, abdominal, ent, ob/gyn, plastic, neurosurgery, thoracic and cardiovascular (channel drains only) procedures.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." (b)(4).
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