The healthcare provider reported that ¿the glue is not secure and the fixation is falling apart, then the catheter is exponated [exposed].This results in that way that the catheter is not fixed.¿ there was no harm to the patient.No photograph depicting the reported issue was provided.Although requested, no additional information was provided.
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Corrected data: device manufacturing date.A batch record review indicates no discrepancies.Batch record review was conducted resulting in the following: the production process, in-process control, testing result, sterilization, visual inspection, and packaging of products showed that all the results were within specification and products were released.Photograph and samples has not been received for this complaint.Review of the device history review (dhr) showed that all relevant tests required during the manufacturing process, packaging process and final product release had been fulfilled and met the requirements.No nonconformity has been registered during the manufacturing process of the mentioned lot.No another complaint of this nature on the affected lot has been registered or received.This issue will be monitored through the post market product monitoring review process.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).
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