The reported event was confirmed use-related.The device was not returned for evaluation.The device was being used for treatment at the time of the reported event.A failure mode was 'loss of vacuum pressure.¿ with the root cause of 'tubing/wound drain is damaged.¿ the lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿warnings #10 (c-f) states: 10.To avoid the possibility of drain damage or breakage, please follow these steps: a.Avoid suturing through drains.B.Drains should lie flat and in line with the skin exit areas.C.Particular care should be taken to avoid any obstacles to the drain exit path.D.Drains should be checked for free motion during closure to minimize the possibility of breakage.E.Drain removal should be done gently by hand.Drains should not be handled with pointed, toothed or sharp instruments as these could cause cuts or nicks and lead to subsequent structural failure of the drain.F.Surgical removal may be necessary if drain is difficult to remove or breaks." h11: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.H3 other text : the device was not returned.
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