Device 44 of 50.(b)(6).Based on the available information, this event is deemed to be a reportable malfunction.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.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).
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It was reported ¿the clear, sticky plastic that wraps around the tube comes loose after twenty-four (24) hours.I'd say the tube section mentioned broke or the clear plastic loosened, so the tube moved and pulled my catheter tube approximately fifty times at least in the past six months.¿ she stated there was "no bleeding but extreme irritation of supra pubic tract and is worried of possible infection from catheter pulling since the strap securement device often moves down her leg." no confirmed diagnosis of infection reported.No photographs depicting the reported complaint issue were received.
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