The reported event was confirmed as use related as the device was used for 16 days.Visual inspection noted one foley statlock was received.Visual evaluation noted the clamp was disconnected from the pad on return.The root cause for this failure was due to the statlock not changed within clinically indicated timeframe.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: "the statlock® device should be assessed daily and changed when clinically indicated, at least every seven days." 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.
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