The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s), labeling, applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a plastic retainer disconnection was confirmed but the exact cause remains unknown.Four cv plus statlock securement devices were returned for investigation.One package was returned and contained product information lot: judy2115.The plastic retainer portions on the four devices were returned completely separated from the dressing pad.Evidence of use was visible on each of the returned samples.Tactile evaluation of the adhering surfaces showed adhesive to be present on all four samples.Microscopic observation of the samples revealed adhesive to be present between the retainer base and the pad contact surfaces.A review of the manufacturing and device history records (dhr) did not reveal any evidence to suggest a manufacturing related root cause contributed to the reported event.Based on the condition of the returned samples, possible contributing factors include adhesive weakening due to antiseptic or cleaning solutions and forces applied during use.The product instructions for use (ifu) precautions state, "do not use the statlock device where loss of adherence could occur, such as with a confused patient, diaphoretic or nonadherent skin, or when the access device is not monitored daily" and "avoid contact with alcohol or acetone, both can weaken bonding of components and the statlock pad adherence." a lot history review (lhr) of judy2115 showed six other similar product complaint(s) from this lot number.The complaints for this lot number (judy2115) have been reported from the same facility in (b)(6).
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