This report has been identified as b.Braun medical inc.Internal report number (b)(4).The actual device involved in the reported incident was not returned, however a photo was provided for evaluation.Upon examination of the provided photo, the manufacturer did confirm that there was some kind of foreign material present.Since the actual device was not returned, the foreign material could not be tested to determine if the material was a spider or insect, or some other foreign material from the manufacturing process.As a result, no specific conclusions on the root cause can be drawn.Review of the device history record performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.If additional pertinent information becomes available a follow-up report will be filed.
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