B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.6 investigation summary: no samples were received for investigation of complaint reference (b)(4) reported via post market survey; however, the customer has indicated that a faulty pinch clamp was detected during use of the bd alaris extension set, as the pinch clamp would not remain clamped.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.D.4 device expiration date: unknown h.4.Device manufacture date: 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 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.
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