The manufacturing location for this product is (b)(4).This site is not registered with the fda.Therefore, bd corporate headquarters in (b)(4) has been listed as the mfr site and the franklin lakes fda registration number has been used for the manufacture report number.Two photos were received by bd for evaluation.A quality engineer was able to review the photo of item #: 301285 from lot#: 2012403 regarding the reported issue of blood leakage.The investigation and simulation were carried out on ten retention samples where the investigating team has visually tested the samples for blood leakage and no blood leakage was found in the ten retention samples.Since no sample and two photographs received were not helpful to investigate further, the complaint could not be confirmed, and investigation could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.
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