No specific corrective action due to mitigative prevention of hazards is assigned to this report.A review of the relevant device history records and the raw material history files did neither indicate recorded qual problems nor rejections related to this incident.If any further info is becoming available, mfr immediately will inform fda.If no further info is becoming available, mfr considers this file as closed.After evaluation of the data, the failure was caused at the mfg of the catheter.At the end control, the failure was not detected and the faulty products thus not sorted out.This is not a systematic product failure, the failure is limited to individual items.
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