A review of the dhr and inspection records was conducted, and no similar concerns were found.According to the product experience report there was no sample available for review.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence, the results are inconclusive.However, based on the number of complaints regarding the same issue with this part number, this complaint will be confirmed.Several complaints for this part number have previously been received regarding a cracked hub resulting in leakage, and capa 2021-039 was initiated to address this issue.The capa is currently in the implementation phase and will evaluate the corrective action implementation for effectiveness to prevent a recurrence of this issue.
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Cracked hub.Insertion: (b)(6) 2023.After reviewing the records, each event occurred with or following a dressing change.According to the nurses, no excessive force was used during the connection of the ¨smallbore extension set¨.In general, babies have been pricked more than once to obtain new venous access.No infection related to broken equipment.(b)(6) 2023 replacement by another central line.
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