The reported event was inconclusive as no sample was returned for evaluation.A potential root cause for this failure could be "fading, staining, solvent deterioration".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: "instructions for silicone self-adhesive sheath note: do not use on irritated or compromised skin.Do not use if allergic reaction occurs.If sheath has an insert, remove it (figures 1 & 2).Application: figures 3 & 4.Removal: figure 5.Not made with natural rubber latex." 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.H3 other text : the device was not returned.
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