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Patient 1
INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT ((B)(4)) WAS RECEIVED INDICATING AN ANGIOGRAPHY KIT (PART 89-9920, LOT 48815217) CONTAINED A SYRINGE WITH A SHARP FLANGE THAT LED TO A TECHNICIAN SUSTAINING A MINOR INJURY. THIS OCCURRED DURING A PROCEDURE AND ALSO CAUSED THE TECHNICIAN'S GLOVE TO BE CONTAMINATED. TWO SYRINGES WERE RETURNED MARCH 7, 2019, TO DEROYAL. BARBS WERE OBSERVED ON BOTH OF THE RETURNED SYRINGES, CONFIRMING THE REPORTED ISSUE. THE WORK ORDER FOR THE FINISHED GOOD KIT WAS REVIEWED FOR DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO DISCREPANCIES WERE IDENTIFIED. THE BILL OF MATERIALS WAS REVIEWED AND RAW MATERIAL (B)(4) (SYRINGE 20CC) WAS IDENTIFIED AS THE AFFECTED KIT COMPONENT. THIS SYRINGE IS SUPPLIED TO DEROYAL BY BECTON-DICKINSON. THE 2017-2019 SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) AND SUPPLIER NOTIFICATION LETTER LOGS WERE REVIEWED FOR SIMILAR COMPLAINTS. SIMILAR REPORTS WERE IDENTIFIED, AND A SCAR WAS ISSUED TO BECTON-DICKINSON. THE AFFECTED SAMPLE ALSO WAS FORWARDED. AS OF THE DATE OF THIS REPORT, A SCAR RESPONSE HAS NOT BEEN RECEIVED. THE INVESTIGATION IS ONGOING. WHEN NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.