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 franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.B.3.Date of event is unknown; awareness date has been used for this field.H6: investigation summary: no samples were received for investigation of complaint reference pr 8081384 reported via post market survey; however the customer suggested that connection issues were detected during use of a bd smartsite secondary set, with the customer indicating they had to exert force to connect the infusion set.No further information was available to assist the investigation in this instance.In this instance a lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.The root cause of the customer¿s experience could not be determined as the sample was not available for investigation.In this instance, without a sample, it is not possible to determine whether a manufacturing defect could have caused or contributed to the customer¿s experience.In this instance, without the complaint sample or additional information about the exact nature of the defect it is not possible to conclusively link this feedback to a specific failure mode.H3 : see h.10.
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It was reported while using unspecified bd smartsite the connection was too tight.There was no report of patient impact.The following information was provided by the initial reporter: it was reported that clinician and/or any of your patients encountered connectivity issues when using the bd smartsite¿ secondary set without inline 0.2 filter / light resistance in the last 2 weeks.Verbatim: clinician experienced: connectivity issues, difficult to screw onto the line, it jumped and you had to exert force.
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