It was reported that during use a bd insyte was found leaking as ¿after the patient's canalization, blood was seen leaking out of the catheter cone, the catheter was removed.¿ there was no report of exposure, injury or medical intervention needed.
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Investigation summary: not confirmed: bd was unable to confirm the incidents of ¿peelback¿ and ¿leakage¿.Investigation comments: it was not possible to confirm this claim, since the client's photos containing the sample claimed did not demonstrate the defect claimed as ¿peelback¿ and ¿leakage¿.In addition, batch history analysis and nonconformity analysis did not demonstrate clear evidence of the incident in question.Samples/ photos: after analyzing the photos, no defects were observed in the product, since the photos did not have a good resolution.According to the analysis of the attached photo "photo", it can be seen that the tip of the catheter was crooked, but the set catheter/ adapter assembled had been moved from its original position, therefore, it is not possible to know if the observed characteristic comes from the manufacture the product or the handling of the product during its use.Dhr review: the following assembly batches used in the final claimed product list 7118819 were analyzed: the final assembly lot: 711607 assembled at (b)(4) in the period from 05 to 05/05/2017.The assembly lot of the catheter: 7116622 performed at (b)(4) in the period from 05 to 05/05/2017.Both batches were tested for damaged catheter, transfixed catheter, and leak tests in addition to all other tests, and no records were found that could clearly point to a cause of "peel back" and "leakage" defects.Qn/ ncmr review: no records of quality notification or reports of non-conformity that could lead to incidents in to the lot involved in this complaint were evidenced.Investigation conclusion: based on the information of this complaint, it was not possible to determine a root cause for this issue.
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