Based on the available information, this event is deemed to be a reportable malfunction and a non-serious injury.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.Additional details have been requested but not provided to date.Should additional information become available, a follow-up report will be submitted.
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Complaint reported, "catheter inserted, flexi-track attached, patient showered the next day, nurse finds flexi-track flaps/tabs have detached and catheter is no longer attached causing trauma for the bladder neck, urethra and discomfort for the patient.At times there will also be bleeding from trauma at catheter site." the reporter clarified that there was "no hemorrhage but blood around site caused through the trauma of the detachment".No further information was provided.
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