The device was not returned for evaluation.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: ¿sterilized using ethylene oxide.Sterile unless package is opened or damaged, except for any individually packaged components within the pouch which are not labeled as sterile.These components are not terminally sterilized.Do not alter the statlock® device or components.Procedure must be performed by trained personnel with knowledge of anatomical landmarks, safe technique and potential complications.Not made with natural rubber latex contents: package includes statlock® stabilization system and skin preparation pad.Indications for use: the statlock® device is a stabilization device for compatible catheters.Contraindications: known tape or adhesive allergies.Warnings and precautions: 1.Do not use the statlock® device where loss of adherence could occur, such as with a confused patient, unattended access device, diaphoretic or non-adherent skin.2.Observe universal blood and body fluid precautions and infection control procedures, during application and removal of the statlock® device.3.Minimize catheter manipulation during application and removal of the statlock® device.4.Daily maintenance a.The statlock® device should be assessed daily and changed when clinically indicated, at least every seven days.B.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.C.If showering/bathing, cover with plastic wrap or waterproof dressing.D.Conduct skin assessment prior to application and repeat daily per facility protocol.E.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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