It was reported that foreign matter was found on the tip of the bd saf-t-intima¿ iv catheter safety system needle.The following information was provided by the initial reporter, translated from chinese: "on (b)(6) 2021, the patient underwent indwelling needle puncture.When the indwelling needle was opened for examination, foreign body was found at the tip of the needle, and the indwelling needle was replaced.There were no adverse effects on the patient.".
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Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received. the lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly. our business team regularly reviews the collected data for identification of emerging trends.
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