UNOMEDICAL ZAVODSKAYA STREET 50 L3C2250 - UNO OR/WOUND DRAINAGE; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
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Model Number 40105181 |
Device Problem
No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Mdr 3007966929-2021-00038 / device 1 of 2.Contact office address: (b)(4).Affiliation: (b)(6) university hospital.Based on the available information, this event is deemed to be a reportable malfunction.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 "bellows does not hold vacuum.User need to activate the bellows repeatedly.Two of twenty product has this issue.Risk that the exudate will not leave the wound." no harm was reported.No photos provided.
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Manufacturer Narrative
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Correction (g1) - contact office address: (b)(6).A batch record review was performed.No ncr related to complaint issue were initiated for complaint order during production.No samples and pictures were received.Root cause investigation was performed via event tw #1382290 ¿handyvac cannot hold the vacuum¿.On the base of the available information the investigation reveals the likely causes for the issue the new deht tube material changes properties with time and the connection between the tube and male, female connectors weaken.As a result, the connector in the tube began to turn.After shifting the connector, a small ¿channel¿ is formed in the tube through which air can enter."channel" is an imprint of the line of contact between two parts of the connector during molding.It happened because the tube is too rigid and has lost elasticity.And handyvac can't work correctly.Capa tw #1293438 was opened to implement new deht material for handyvac tubes.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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