Based on the available info, this event is deemed a reportable malfunction.There were no reports of the pt being harmed as a result of this malfunction.It was also reported, "the lot number (156456) is the one the complainant gave me when first discussed the issues on the unit.She thinks the catheters came from this is the lot number.No bags or packaging were kept and so cannot definitely confirm this," thus the lot number reported is not being utilized to capture this event.Note: issue occurred on (12) separate cases.A separate 3500a form has been completed for the other (11) cases.Should add'l info become available, a follow up report will be submitted.(b)(4).
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