Investigation summary: "material # unknown.Lot/batch # unknown.Bd had not received samples or photos for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.This complaint is unable to be confirmed.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends." medical device expiration date: unknown.Device manufacture date: unknown.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 franklin lakes fda registration number has been used for the manufacture report number.
|
It was reported when using an unknown bd abg syringe after collecting blood, the blood flows from the syringe to the push rod.The following information was provided by the initial reporter.The customer stated: after collecting blood, blood flows from the syringe to the push rod.".
|