UNOMEDICAL LTD. UNOMETER¿ SAFETI¿ PLUS - WITH LUER-LOCK & LUER; DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
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Model Number 158100140190 |
Device Problems
Biofilm coating in Device (1062); Collapse (1099); Obstruction of Flow (2423); Sediment, Precipitate Or Deposit In Device Or Device Ingredient (3021)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/08/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).Expiration date (08/2020).Manufacturing date (09/2015).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: october 11, 2016.(b)(4).
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Event Description
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Complainant reported that a patient in icu was cauterized on (b)(6), with a urinary foley catheter and a unometer system."on (b)(6), after eight (8) days of usage, the nurse observed sediment and biofilm in the sampling port during a urine sampling and sediment in the measuring chamber.The tubing of the system collapsed after being vacuumed and was changed according to the instructions of the infections committee." no further details have been provided.
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Manufacturer Narrative
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Device history records were reviewed.No non-conformance was initiated.Sterilization was performed in accordance with parameters.The batch was released according to requirements.A batch record review indicates no discrepancies initiated during production.The batch record review resulted in a discrepancy which was investigated in another complaint and is closed.No additional investigation is needed.A photograph has been received for this complaint, which was evaluated.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.Reported to the fda on november 03, 2016.(b)(4).
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Search Alerts/Recalls
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