The device was not returned for evaluation.A potential failure mode could be ¿clamp door opens unintentionally / incomplete engagement " with a potential root cause of ¿inappropriate snap fit ".The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following:¿do not use the statlock® device where loss of adherence could occur, such as with a confused patient, diaphoretic or non-adherent skin, or when the access device is not monitored daily.Observe universal blood and body fluid precautions and infection control procedures, during application and removal of the statlock® device.Minimize catheter manipulation during application and removal of the statlock® device.Daily maintenance: the statlock® device should be assessed daily and changed when clinically indicated, at least every seven days.If pad becomes soiled, wash with soap/water, saline or hydrogen peroxide.Do not use alcohol or prepackaged bathing systems, which could lead to early lifting.If showering/bathing, cover with plastic wrap or waterproof dressing.Conduct skin assessment prior to application and repeat daily per facility protocol.Use clinical judgment on the removal of the statlock® stabilization device if the patient experiences any fluid shifts that may interfere with skin integrity." the device was not returned.
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