The reported issue was confirmed.The device was returned for evaluation.Visual inspection noted one opened (without original packaging), used (note wear and tear on base and presence of biological fluids) foley statlock swivel base.Visual inspection of the sample noted wear and tear, but no obvious visible defects.The sample was tested.The clamp was able to open and close properly.A 16 fr foley catheter was inserted into the device.The clamp door was able to close.The statlock opened with very little force applied to the catheter.A potential root cause for this failure could be, ¿material weakens due to sterilization." 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: ¿warnings and precautions: 1.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.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." 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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