Model Number 25039742 |
Device Problem
Disconnection (1171)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)
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Event Date 11/06/2014 |
Event Type
malfunction
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Event Description
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A unit clerk reported on behalf of staff nurses the device's tube disconnected from the patient's catheter during use.As a result urine has leaked onto the patient's bed.
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Manufacturer Narrative
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Based on the available info, this event is deemed a reportable malfunction.There are five (5) additional cases with similar problems manufactured under the same lot.Additional mdr (3500a) reports will be submitted for each case.There were no reports of the patient being harmed as a result of this malfunction.No additional patient/event details have been provided to date.Should additional info become available, a f/u report will be submitted.(b)(4).
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Manufacturer Narrative
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A quality investigation was performed.Product samples were not available to assist with the investigation.The device history record (dhr) was reviewed and there were no related non-conformances concerning the complaint issue.Additional information was requested regarding the complaint issue, but no additional information was received to date.The issue is related to the foley catheter, which is not a part of the product.No information about the catheter was provided.The root cause cannot be identified based on the information received.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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Manufacturer Narrative
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Add'l information was received.A complaint query was generated using the following parameters: date range of oct/28/2014 to apr/08/2015; brand name type: unometer 500-urinemeter.The results of the query identified a total of 30 reported complaints for this reported complaint issue- connection issues.Six were identified as being associated with ref number (b)(4).No additional patient/event details have been provided to date.A return sample for evaluation is not expected.Should additional information become available a f/u report will be submitted.
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Manufacturer Narrative
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On december 21, 2015, it was discovered the brand name listed on the initial report was incorrect.The brand name has been updated.
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Search Alerts/Recalls
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