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Patient 1
INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT WAS RECEIVED INDICATING THAT A 10 CC SYRINGE CONTAINED WITHIN DIAGNOSTIC ANGIOGRAPHY PACK (FINISHED GOOD (B)(4), LOT 44720632) CRACKED WHEN DRAWING BLOOD. THE DEFECTIVE SAMPLE WAS NOT AVAILABLE FOR RETURN. THE WORK ORDER FOR THE REPORTED LOT WAS REVIEWED FOR DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE EVENT. NO DISCREPANCIES WERE IDENTIFIED. LOT MAPPING IDENTIFIED THE AFFECTED COMPONENT TO BE RAW MATERIAL (B)(4) -- A 10 CC SYRINGE SUPPLIED TO DEROYAL BY (B)(4). A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) HAS BEEN ISSUED TO (B)(4). AS OF THE DATE OF THIS REPORT, A RESPONSE HAS NOT BEEN RECEIVED. THE 2014-2016 SCAR AND SUPPLIER NOTIFICATION LETTER LOGS WERE REVIEWED FOR SIMILAR COMPLAINTS, AND SIMILAR COMPLAINTS WERE IDENTIFIED. THE INVESTIGATION IS ONGOING AT THIS TIME. WHEN NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.