In additional conversations with the laboratory regarding the composition analysis, it was discovered that upon receipt at the laboratory the syringe contained multiple small round particulates.Given that the small round particulates were not reported by the customer, these are believed to have formed in the syringe during shipment to the laboratory.The laboratory confirmed they had initially extracted a small round particulate for analysis.This analysis corresponded to the inconclusive result.A photo supplied by the customer of the thread-like object was submitted to the laboratory and the laboratory recovered and analyzed the thread-like object.The thread-like object has a significant match to polycarbonate.Given the appearance of the particulate and that the injection site is the only component made of polycarbonate, it is likely that the particulate was due to a needle strike with the inner wall of the injection site during the filling of the bag.As the bag was discarded by the customer, the injection site was not available for review.Should additional relevant information become available, a supplemental report will be filed.
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