UNOMEDICAL ZAVODSKAYA STREET 50 UNOMEDICAL OP-FLEX POOLE SUCTION SET; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE. NONPOWERED
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Model Number 34071181 |
Device Problems
Delivered as Unsterile Product (1421); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/06/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Mdr 3007966929-2020-00018 / device 1 of 1.(b)(6).Device date of manufacture: oct 2019.Based on the available information, this event is deemed to be a reportable malfunction.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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Event Description
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It was reported "the operation was about to begin, and the upper part of the suction had been removed.At this point a fly came out of the suction.Luckily, the suction had not yet been used." additional information was requested and received informing ¿we are unwrap the component prior to packing in to the ppack.The product was discarded.Yes, it was found after taking off the op-flex, so yes it was inside the device.¿ a photograph depicting the reported complaint issue was provided by the complainant.The product was not used on the patient, no harm reported.
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Manufacturer Narrative
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A batch record review was performed.No non -conformance report (ncr) related to complaint issue were initiated for complaint order during production.No samples were received.Picture was received and evaluated.Defect is confirmed on the base of picture.An ncr was initiated to investigate the issue.The intention of this investigation was to describe and identify the root causes for issue ¿foreign matter in the op-flex poole set/x-ray¿.On a base of the available information the investigation reveals: the root cause for the issue is not fully effective pest control at the factory.This is an isolated case.The following actions are planned to be implemented: add electronic fly killers in unprotected areas; control of maintenance electronic fly killer; additional protection during the movement of components along the conveyor.Retraining of service company on c705003 must be performed.A corrective/preventative action (capa) has been initiated.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.Fda registration number, reporting site: 1049092, manufacturing site: 3007966929.
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Event Description
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To date no additional patient or event details have been received.
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Search Alerts/Recalls
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