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.Date of event: unknown.The date received by manufacturer has been used for this field.Date of death: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.The customer's address is unknown.Unknown, (b)(6) usa has been used as a default.Fda notified?: the initial reporter also notified the fda via medwatch # (b)(4).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.
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It was reported that the unspecified bd¿ syringe was used to administer the pfizer vaccine, which caused the patient to have an allergic reaction, including a rash and fainting.They were taken to the hospital, were they recovered after an unspecified amount of time.However, "after a month or so" of receiving the vaccine, the patient passed away.No further information has been received.The following information was provided by the initial reporter: "'i had a friend that died 2 weeks ago after receiving the covid vaccine.They are going to search for the cause of death (autopsy) because after the vaccine she had a rash, fainted, went to the hospital, she recovered.But after a month or so (uncertain) she passed away.' caller says the woman was born a very unhealthy person.'i cannot tell you even the name, i never met her, she is a niece of a friend of mine.'".
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