The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿materials of construction are not biocompatible,".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "warning: on catheter, do not use ointments or lubricants having a petroleum base.They will damage the catheter and may cause balloon to burst.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws, regulations, and policies.Keep away from sunlight.Do not store at freezing temperatures, keep at room temperature away from direct exposure to light, preferably in original box.Sterile unless package is opened or damaged, except for any individually packaged components within the tray which are not labeled as sterile.These components are not terminally sterilized.This is a single use device.Do not resterilise any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient." h11: section a through f - the information provided by bard 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 bard.
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