The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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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The reported issue (the iodine pack had leaked inside of the tray), was confirmed, as unknown.During the visual evaluation was found the iodine leaked.The swab stick damaged the iodine package.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: ¿contents: this preconnected closed system foley tray includes: bardex® all-silicone foley catheter, statlock® foley stabilization device, tamper evident tubing junction seal, ez-lok® needleless urine sample port, 2000ml (approx.Vol.) collection bag, anti-reflux chamber, control-fit¿ outlet device.String hanger, attached sheeting clip, underpad, fenestrated drape, latex-free gloves, 3 antiseptic swab sticks, 10cc lubricating jelly syringe, prefilled 10cc syringe of sterile water, specimen container with cap and label, hand sanitizer, castile soap towelettes sterile unless package is open or damaged, except for the hand sanitizer and castile soap towelettes which are not terminally sterilized." (b)(4).
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