Catalog Number 400714 |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/11/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that 2 anesthesia kits durasafe 18x3-1/2 had damaged packaging before use with some of their iodine envelopes "bursting".The following information was provided by the initial reporter, translated from spanish to english: "at the time of the review, two pieces unfit for sale were found, since iodine envelopes were bursting in some parts.".
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Manufacturer Narrative
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H.6.Investigation summary a device history record review was performed for provided lot number 9304002 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.Although physical samples were sent for review, our quality team is unable to receive these samples at the manufacturing plant.A thorough investigation utilizing other methodologies and available information was completed to the best of our ability through use of the picture samples.The two picture samples confirmed iodine leakage.As our manufacturing facility only packages the final kits, we are unable to identify a definitive cause for the defective iodine packages.The supplier of the iodine material has been notified of this incident for further investigation.Our quality team will continue to monitor the production process for signs of this potential defect and any emerging trends.
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Event Description
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It was reported that 2 anesthesia kits durasafe 18x3-1/2 had damaged packaging before use with some of their iodine envelopes "bursting".The following information was provided by the initial reporter, translated from spanish to english: "at the time of the review, two pieces unfit for sale were found, since iodine envelopes were bursting in some parts.".
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Search Alerts/Recalls
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