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Patient 1
INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT (B)(4) WAS RECEIVED INDICATING THAT A C-SECTION PACK (FINISHED GOOD 89-8636, LOT 44274011) CONTAINED A DRAPE WITH A PIECE OF PLASTIC ON IT. THE AFFECTED DRAPE WAS IDENTIFIED AS A C-SECTION DRAPE WITH POUCH AND FENESTRATION (B)(4). THE SAMPLE WAS INITIALLY REPORTED TO BE AVAILABLE FOR RETURN. HOWEVER, DUE TO THE CONTAMINATION OF THE SAMPLE, IT WAS NOT RETURNED FOR EVALUATION. INSTEAD, A PHOTOGRAPH OF THE REPORTED DEFECT WAS SENT. THE WORK ORDER FOR THE REPORTED LOT NUMBER WAS REVIEWED FOR DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO DISCREPANCIES WERE IDENTIFIED. LOT MAPPING IDENTIFIED THE RAW MATERIAL DRAPE USED IN THE REPORTED FINISHED GOOD LOT WAS SUPPLIED TO DEROYAL BY (B)(4). THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED AUGUST 10, 2017, TO (B)(4). THE PHOTOGRAPH OF THE REPORTED DEFECT ALSO WAS SENT TO THE SUPPLIER. THE SUPPLIER ACKNOWLEDGED RECEIPT OF THE SCAR ON AUGUST 16, 2017. A RESPONSE IS DUE SEPTEMBER 21, 2017. THE INVESTIGATION IS ONGOING AT THIS TIME. WHEN NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.