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.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a foreign material is confirmed but the exact source of the material remains unknown.One siterite needle guide kit was returned opened.The probe cover, ultrasound gel, and needle guides were returned wrapped within the drape.A white, solid material was noted on the surface of the probe cover.The material was spread out unevenly.The material was observed to be firm.A plastic tool was used to apply pressure to the white material and impressions were observed to be retained.The photos were forwarded to the manufacturing facility for further evaluation and the determination of the root cause remained unknown.No findings from a manufacturing review indicated a manufacturing/processing related cause.Possible contributing factors include deposition of the foreign material prior to or after kit packaging.Therefore, as the definitive root cause or source of this contamination could not be determined, the cause remains unknown.H3 other text : device evaluation findings are in the manufacturer's note.
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