On 21 september 2022, (b)(6) notified avi of a complaint.(b)(6) reported that a nurse, (b)(6), was consulted for a hydropicc that was leaking.When she determined it was not phlebitis, the catheter was removed and "crack" was observed just distal to the reverse taper.A video was provided showing blood leaking from the catheter just under the skin.An image was also provided to show the suspected crack post-removal.Per request, (b)(6) participated in a phone call on the same day with members of the avi quality team ((b)(4) and (b)(4)).(b)(6) indicated on the call that the hospital record reflects insertion to be 1cm from the suture wing or insertion site (1cm is the recommended insertion on the hydropicc instruction for use).(b)(6) noted that from the video the insertion appears to be approximately 3-4cm from the insertion site.Based on the catheter defect type and location, (b)(6) suspects the additional catheter length outside the insertion site dehydrated resulting in the crack during catheter use.Upon further discussion, it was noted that (b)(6) has had issues with this particular site not following proper care and maintenance procedures in the past, and he suspects that a dressing change was not done properly.After the catheter was removal, a new hydropicc was placed.The lot# of the picc-142 catheter/kit was not provided, therefore, avi is not able to complete an lhr review to review production documentation as part of this investigation.Additionally, there have been no other lots associated with this reported issue.
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