Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and 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.Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.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.
|
It was reported that air leaked from the damaged unspecified bd connecta¿ stopcock packaging before opening it.The following information was provided by the initial reporter, translated from (b)(6) to english: "on (b)(6) 2021, the patient.Entered the operating room at 08:00 and planned to undergo bilateral maxillary sinus, frontal sinus, sphenoid sinus, open surgery + bilateral nasal polypectomy under the dynamic cutting system under nasal endoscopy.Preoperative preparation had been completed at 08:30.When the connecta for infusion was applied after venipecesis, air leakage was found in the package of the connecta, which was replaced in time.".
|