Device 1 of 2.Uno handyvac ch18 bag sw/tap (1/20) int.Correction - contact office address: (b)(4).Affiliation: (b)(6) 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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Correction (g1) - contact office address: (b)(4).7815 national service road suite 600 greensboro, nc 27409 (b)(4).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 #(b)(4) ¿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 # (b)(4) 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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