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The customer reported that when customer opened pack it appears one of the items leaked onto another, and the account reported finding pvp leaked.A photo and a physical sample for one unopened pack were received; medline observed through the breather pouch an orange stain leaked through the back table cover, and upon opening the pack, discovered that the pvp bottle fluid had leaked inside, with the bottle cap fully tightened and not loose.The sample evaluation confirmed the reported issue, and the vendor added water to the returned sample and the sample failed inspection confirming the leaking.The investigation initially stated that a molding defect within the cap was the cause of the leaking; the vendor later determined the root cause to be the crack in the neck of the bottle, however the vendor is unable to determine how the crack occurred, and no additional corrective actions were implemented.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.
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