NULL PORTEX ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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Catalog Number C49291349-NLJ |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/18/2021 |
Event Type
malfunction
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Event Description
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It was reported that during a pre-use check, a crack was found in the breathing circuit.No patient injury was reported.
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Manufacturer Narrative
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No lot number was provided; therefore, device history record review could not be completed.A product sample and pictures were received for evaluation.Visual and functional testing were performed.It was observed in pictures that the circuit had a tear.The sample was received in used conditions without original package.The sample was visually inspected at a distance of 12" under normal lighting to received unit, in order to detect any damage on the units, and the physical evaluation confirmed that the sample unit had a tear.The most probable root cause of the reported issue was found to be that the product became damaged after it left the manufacturing facility.No corrective actions are required since failure mode is not attributable at the manufacturing process since all products are 100% leak tested; if a tear damages a circuit surface couldn?t pass the leak test.Udi is unknown.Operator of device is unknown.Manufacturer site address is unknown.Pma/510(k) is unknown.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).
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