It was reported by that during a veterinarian procedure on (b)(6) 2018, suture was used.During the procedure, the needle of suture bent the suture separated from the needle at the swage.The procedure was completed another suture.No additional information is available.
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(b)(4).An actual sample was returned for evaluation.During the visual inspection of the opened sample, the channel of the needle was open resulting in an incorrect swage and the cause of the detached.In addition, the shape of the needle was distorted at middle of the body and marks that appears to be by use of surgical instruments were found.Due to this damage, the comparison test of the needle with the drawing was not met.The suture was not returned for analysis.According to the sample condition the assignable cause of performance pull off suture needle, is an open channel defect.Representative samples were returned for analysis.During the visual inspection of unopened samples, the sample was opened and the swage and attachment area of the needle were not as expected; since open channel was observed in the needle resulting in an incorrect swage defect.The suture was dispensed without problems and examined along of the strand and no defects were observed.Also, the curve of the needle was comparison with the drawing of needle specification and fall within of curve tolerance shadow lines.The sample was tested by needle pull and meet the finished goods requirements.
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