H10: manufacturing review: a dhr review was requested to review manufacturing records due to the nature of the complaint.The device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate that there was a manufacturing related cause for this event.Investigation summary: one bard ptfe felt was returned for review.A stain was noted on the bottom portion of the outer package (tyvek).Therefore, the investigation is confirmed for foreign material present in device.It is possible that the alleged contamination occurred during shipping and handling or at the user facility.It cannot be confirmed that this contamination is manufacturing related.Based upon the available information, the definitive root cause is unknown.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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