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 event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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It was reported unspecified bd introsyte¿ introducer was involved in 2 cases of bleeding requiring unspecified intervention, 2 cases of infection with no device malfunction reported, and 2 cases of incorrect splitting of the sheath which may have required additional medical intervention.The following information was provided by the initial reporter: "bleeding requiring medical intervention related to insertion of the introducer - 1, infection (within 24-48 hours after insertion of the introducer) - 1, incorrect/incomplete splitting of the introducer upon its removal, requiring the removal of the device being inserted through the introducer - 1, bleeding requiring medical intervention -1, infection (within 24-48 hours after insertion of the introducer)- 1, incorrect/incomplete splitting of the introducer upon its removal, requiring the removal of the device being inserted through the introducer - 1.".
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