UNOMEDICAL LTD. UNOMETER SAFETI+,150CM,2L,RH; DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
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Model Number 158101310190 |
Device Problem
Leak/Splash (1354)
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Patient Problem
Missing Value Reason (3192)
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Event Type
malfunction
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Manufacturer Narrative
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Based on the available information, this event is deemed a reportable malfunction.No patient harm was reported.Additional information has been requested but not received to date.When additional information becomes available, a follow-up report will be submitted.Reported to the fda on (b)(4), 2016.(b)(4).
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Event Description
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Complaint received reporting that "there is a leak between the chamber and the pouch at the top of the pouch." no further information was available.
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Manufacturer Narrative
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The device history records were reviewed and the batch was released according to requirements.The manufacturer did not find any nonconformity during the production lot.All relevant tests during production of the affected lot# 223486 were performed, registered and the results were in compliance with requirements.Machine logbooks were checked.Due to technical problems with the tearing station and the change of the grippers at the tearing system these were registered in the machine logbooks and the production staff was notified of the defect.A query was run against lot# 223486 which yielded 7 associated occurrences.A non-conformance (nc) was opened and investigated in an associated complaint.The nc has been closed and no additional action is required and this complaint will be closed.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.
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Search Alerts/Recalls
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