HEMASHIELD PLATINUM WOVEN STRAIGHT

Additional Manufacturer Narrative

(10/3233) IT WAS REPORTED THAT THE INVOLVED DEVICE IS AVAILABLE, IT SHOULD BE RETURNED TO INTERVASCULAR FOR EXAMINATION. (4109/213) THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME STERILIZATION LOT NUMBER 23G05. (4121/213) THE DEVICE HISTORY RECORDS REVIEW CONCLUDED THAT THERE WAS NO NON-CONFORMANCE IN RELATION WITH THE EVENT REPORTED. (11) THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

IT WAS REPORTED THAT PRIOR TO USE THE CUSTOMER OBSERVED LITTLE DOTS INSIDE THE PACKAGING AND THE PRODUCT WAS NOT USED. COMPLAINT # (B)(4).

Additional Manufacturer Narrative

CORRECTED DATA: ON BLOCK H6, THE MEDICAL DEVICE PROBLEM CODE "2975" WAS UPDATED TO "1506". ADDTL MFG NARRATIVE: (10/213) THE INVOLVED DEVICE WAS RETURNED TO INTERVASCULAR FOR EXAMINATION. A VISUAL INSPECTION WAS PERFORMED BY THE QUALITY ASSURANCE ENGINEER, MANUFACTURING SUPERVISOR AND MANUFACTURING LEAD OPERATOR. IT WAS CONCLUDED THAT THE INVOLVED PRODUCT IS CONFORM TO THE PRODUCT SPECIFICATIONS. INDEED, THE LITTLE DOTS OBSERVED BY THE CUSTOMER ARE TRANSLUCENT PARTICLES IDENTIFIED AS COLLAGEN FILAMENT WHICH ARE INHERENT PART OF THE PRODUCT. (67) BASED ON THE VISUAL INSPECTION THE PRODUCT IS CONFORM TO THE PRODUCT SPECIFICATIONS. INDEED, THE LITTLE DOTS OBSERVED BY THE CUSTOMER ARE TRANSLUCENT PARTICLES IDENTIFIED AS COLLAGEN FILAMENT WHICH ARE INHERENT PART OF THE PRODUCT AND, PER ACCEPTANCE CRITERIA, SMALL COLLAGEN PARTICLES ARE ROUTINELY ACCEPTED.

Description of Event or Problem

COMPLAINT#: (B)(4).