Reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or any other technological characteristics with a medical device that is registered within the u.S.(b)(4).Manufacturing site evaluation: evaluation on-going.
|
Samples received: 1 open cassette.Analysis and results: there are no previous complaints of this batch.Manufactured and distributed in the market (b)(4) units of this batch.There are no units in stock.Received one open cassette.Diameter result conducted on thread of the cassette received has values that correspond to a usp 0 size instead of usp 3/0 size, as the product description.Reviewed the batch manufacturing record, a re-work was carried due to wrong version print on the label.This defect took place in the manufacturing line.The cassette pack was labeled as dafilon usp 3/0 instead of dafilon usp 0.Taking into account that no other customer complaints have been received for this batch, we consider that this in an isolated and accidental cassette affecting only this article code batch.Corrective/preventive actions: the following actions are proposed to avoid this defect: - henceforth all the cassette pack requiring re-work will be processed in dedicated re-work bins with proper identification.- relevant sop will be updated with necessary revision and training will be provided to concerned persons.
|