Investigation summary: since no photos or samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.Examination of the product involved may provide clarification as to the cause for the reported failure.A device history record review showed no non-conformance's associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.No capa - based on an evaluation of severity and frequency, no corrective action was performed, based on the investigation conclusion the condition reported by the customer was not confirmed.
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It was reported that sticky, jelly-like foreign matter was found at the needle while using bd saf-t-intima¿ iv catheter safety system.There was no report of patient impact.The following information was provided by the initial reporter, translated from (b)(6) to english: "the nurse in charge checked the disposable consumables while indwelling the trocar for the patient, and found that there was a sticky jelly-like object at the needle, which was not used by the patient, and the consumable was replaced for the patient's puncture.".
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